• General Food Items: The price of individual food items (excluding capsules and tablets) shall not exceed USD 1,000 and weigh less than 6 kilograms.
• Capsules and Tablets: Travelers may bring a maximum of 12 bottles (including boxes, cans, packs, and bags) per type, and the total quantity per single import shall not exceed 36 bottles in their original packaging.

Keep It Personal: No Resale Allowed

The TFDA emphasizes that imported products under the "personal use" exemption cannot be sold or distributed. Selling these products constitutes a violation of Article 30 of the Act Governing Food Safety and Sanitation. Under Article 47 of the same Act, violators face fines ranging from NT30,000 to NT3,000,000.

Know Before You Go

For more detailed information, please visit the official TFDA website [http://www.fda.gov.tw].

Three-Pronged Approach: Treatment, Screening, and Prevention

In response to the World Health Organization’s (WHO) goal of eliminating viral hepatitis by 2030, the Ministry of Health and Welfare (MOHW) held the International Press Conference on Eliminate Hepatitis C at the Chang Yung-Fa Foundation.

President Lai Ching-Te,  and Academician Chen Chien-Jen, Convener of the National Validation Task Force for Hepatitis C Elimination, attended the event. During the conference, officials outlined Taiwan’s achievements in Hepatitis C (HCV) prevention and control, highlighting policy directives such as "Therapy Spearheads Prevention", "Screening Supports Therapy", and "Prevention Secures Outcome " to meet the WHO elimination targets.

Efforts of Cross-Sectoral Collaboration Culminate in Submission of Elimination Report to WHO WPRO

Minister of Health and Welfare Shih Chung-Liang stated that chronic Hepatitis B and C constitute a significant disease burden in Taiwan. To eliminate Hepatitis C, the government has adopted core strategies centered on "Precision Public Health", "Localized Care Delivery" and "Continuum of Care". These strategies aim to provide precise, comprehensive, and effective screening and treatment services.

Since 2003, the government has provided interferon therapy, and in 2017, direct-acting antivirals (DAAs) initiated reimbursement by National Health Insurance (NHI). As of October 2025, over 182,000 patients have received DAA treatment, with a total expenditure of approximately NT$28.7 billion. To boost screening capacity, the government expanded the screening age range to 45–79 years in 2020 and further widened eligibility to those aged 39–79 in 2025. To date, over 7.55 million individuals have undergone screening.

Director-General Shen Ching-Fen of the Health Promotion Administration (HPA) noted that Taiwan’s Programmatic Targets for HCV elimination have surpassed the Gold Tier standards of the WHO’s "Path to Elimination" (PTE). Both diagnosis and treatment rates now exceed 90%. Regarding prevention and harm reduction measures, the average number of sterile needles and syringes distributed per person who injects drugs (PWID) exceeds 150, while blood safety and injection safety have maintained a 100% record.

Having achieved these staged elimination goals, the Administration aims to further reduce the incidence of Hepatitis C and mortality rates attributable to Hepatitis B and C. Future efforts will focus on strengthening screening, health education campaigns to raise public awareness, and improving treatment accessibility. The public is strongly encouraged to undergo screening and seek early follow-up treatment to consolidate the nation's success in eliminating Hepatitis C.

Through cross-sectoral collaboration involving the MOHW’s Department of Medical Affairs, Department of Mental Health, National Health Insurance Administration (NHIA), Taiwan Centers for Disease Control, and Taiwan Food and Drug Administration, alongside the Ministry of Justice’s Agency of Corrections, local health bureaus, medical institutions, and civic organizations, Taiwan has met the conditions to achieve the planned Hepatitis C elimination goal by 2025—well ahead of schedule.

The government plans to submit the "Taiwan Hepatitis C Elimination Report" to the WHO Western Pacific Regional Office (WPRO) by the end of this year. Moving forward, Taiwan remains committed to implementing relevant control measures and sharing its successful prevention and control experiences with the international community

Beginning January 1, 2025, “Formula for Certain Disease” shall appear prominently and conspicuously on the principal display panel of the container or external packaging, in order to clearly differentiate these products from regular foods.

Additionally, for approved Formula for Certain Disease products, the outer packaging must comply with general labeling requirements for packaged foods and must include the following information: (1) The applicable subjects (2) Storage instructions before and after the package is opened (3) Usage and dosage instructions (4) Warning statement: “This product is a formula food for certain disease. It is not suitable for the general population and must be taken under the instruction of a doctor or registered dietitian.” (5) Warning statement: “Increasing the dosage will not help improve this type of disease,” “This product is not for intravenous use,” or similar statements.

    The full text of the regulations is available on the TFDA website for further details: (http://consumer.fda.gov.tw/Law/Detail.aspx?nodeID=518&lawid=829).

The TFDA urges food business operators to retain procurement source documentation (such as invoices, receipts, or certificates) for poultry, livestock, and aquatic products they sell for at least five years to facilitate source tracing. Additionally, consumers are advised to avoid purchasing poultry, livestock, and aquatic products of unknown origin. They should prioritize selecting products with Certified Agricultural Standards (CAS), Traceable Agricultural Products (TAP), production traceability QR codes, or from reputable merchants to protect consumer rights.

To safeguard drug quality and patient safety, TFDA conducts routine inspections of pharmaceutical manufacturers every two to four years, and may also initiate unannounced inspections when necessary. These measures ensure that domestic manufacturers consistently comply with GMP standards. In response to evolving international trends and regulatory challenges, TFDA remains committed to strengthening pharmaceutical GMP management, upholding manufacturing quality, and ensuring the patient safety of medicines.

Cross-border and Cross-sector Collaboration Inspire New Thinking in Public Health

The "2025 Asia-Pacific Health Promotion and Non-Communicable Disease Prevention Workshop" was guided by the Health Promotion Administration (HPA), Ministry of Health and Welfare, and jointly organized by the Asia-Pacific Academic Consortium for Public Health (APACPH), the Collaborating Centres for Health Promotion (CCHP), the Taiwan Association for Global Health Initiative (TAGHI), with support from the Institute of Population Health Sciences, National Health Research Institutes (NHRI) and the Taiwan Public Health Student Association.

The event brought together four distinguished speakers from four countries: Dr. Akila ANDIAPPAN, Deputy Director of Health Screening and Management at the Health Promotion Board, Singapore; Dr. Takahiro HIGASHI, Professor of Public Health and Health Policy at the University of Tokyo, Japan; Dr. Yumi OH, Division Director of the Department of Health Risk Prevention at the Korea Health Promotion Institute; and Dr. Han-Mo CHIU, Clinical Professor of Internal Medicine at National Taiwan University College of Medicine Department, Taiwan, Professor Hsiu-Hsi CHEN from the Institute of Epidemiology and Preventive Medicine at National Taiwan University, Director Hung-Yi CHIOU and Deputy Director Dr. Ya-Wen CHIU from the National Institute of Population Health Sciences, NHRI. Through engaging discussions on topics such as national cancer screening strategies and health promotion policies, the workshop fostered vibrant cross-national and interdisciplinary dialogues among policymakers, academics, and public health professionals.

Focusing on Cancer Screening: Policy Dialogue and Practical Exchange to Strengthen Regional Health Resilience

The two-day workshop focused on the current colorectal cancer screening  policies and strategies. Dr. Akila ANDIAPPAN from Singapore’s Health Promotion Board opened the session by introducing Singapore’s evidence-based experience, highlighting several successful strategies: integrating screening programs into primary care services, deploying mobile screening units to reach underserved populations, promoting multilingual health education to serve diverse communities, and establishing a rigorous quality assurance system. Dr. Yumi OH from the Korea Health Promotion Institute shared Korea’s strategy, which prioritizes early diagnosis and intervention. She also highlighted government efforts to implement community health programs that strengthen public health infrastructure and promote integrated health promotion measures aimed at reducing key risk factors such as smoking, alcohol consumption, and obesity. Professor Takahiro HIGASHI of the University of Tokyo emphasized the critical role of cancer screening in early detection and improved prognosis. However, he also pointed out concerns such as overdiagnosis and overtreatment associated with certain screening methods. Japan’s national guidelines, he explained, are developed with great caution, recommending only screening procedures with strong evidence of mortality reduction, thereby striking a balance between evidence-based policymaking and clinical realities. Finally, Dr. Han-Mo CHIU, a leading expert in colonoscopy in Asia and Clinical Professor of Internal Medicine at National Taiwan University, addressed Taiwan’s current challenges in colorectal cancer screening. He noted the stagnation in screening participation rates in recent years, the lack of improvement in follow-up colonoscopy rates among individuals with positive fecal occult blood test (FOBT) results, the need for advancements in early-stage colorectal cancer treatment, and the often-overlooked risk of recurrence following local excision. Taiwan has promoted colorectal cancer screening through systematic planning, medical collaboration, and public education. These efforts have successfully increased participation, reduced mortality, and lowered healthcare costs. The program has achieved remarkable results and will move toward precision screening in the future.

On the second day of the workshop, the focus shifted to a broader discussion on national cancer screening strategies. Representatives from participating countries took turns presenting overviews of their current national screening policies and the challenges they face during the round-table forum. The discussion was co-moderated by Deputy Director-General Shi-Lun WEI from the Health Promotion Administration also joined the discussion. Government officials and scholars from across the Asia-Pacific region participated in this forum, sharing insights on the implementation of screening strategies in practice, their theoretical foundations, ongoing challenges, and future prospects. The lively exchanges during the session sparked numerous in-depth and forward-looking perspectives, laying the groundwork for potential cross-border collaboration and strategic development in population health.

Director-General Ching-Fen SHEN of the Health Promotion Administration shared Taiwan’s successful experience in colorectal cancer screening and also learnd from the practices of other economies at the 2025 Asia-Pacific Health Promotion and Non-Communicable Disease Prevention Workshop. Director-General SHEN remarked that the workshop not only deepened transnational exchange and policy dialogue on health promotion and cancer screening strategies across the Asia-Pacific region, but also established a solid foundation for stronger academic and practical collaborations between Taiwan and countries in the Asia-Pacific and New Southbound regions. Looking ahead, the Collaborating Centres for Health Promotion (CCHP) will continue to work closely with international partners to address emerging global health challenges. The Center will further strengthen Taiwan’s research and practical capacity in areas such as non-communicable disease prevention and health promotion.

This year’s workshop was endorsed by the APEC Regulatory Harmonization Steering Committee (RHSC) as an official training program. The GRM session brought together nearly 20 experts from the European Medicines Agency (EMA), Japan Pharmaceuticals and Medical Devices Agency (PMDA), the D.K. Kim International Center for Regulatory Science at the University of Southern California (USC), and experts from Taiwan, including the Center for Drug Evaluation (CDE), the Asia Partnership Conference of Pharmaceutical Associations (APAC), and the International Research-Based Pharmaceutical Manufacturers Association (IRPMA). At least 70 participants from multiple APEC member economies, sharing best practices on good registration management and discussing topics such as accelerated approvals for medicines addressing unmet medical needs and combination products. The workshop emphasized interactive learning to foster collaboration and improve the overall efficiency of drug review and submission processes.

The MD session featured experts from PMDA, the Japan Medical Imaging and Radiological Systems Industries Association (JIRA), and experts from Taiwan, including the CDE, Taiwan Drug Relief Foundation (TDRF), Industrial Technology Research Institute (ITRI), and Regulatory Affairs Professionals Society (RAPS) Taiwan Chapter. A total of 34 participants were trained with a focus on the application of International Medical Device Regulators Forum (IMDRF) guidances. Through group discussions and case studies, participants explored the full life-cycle management of medical devices and exchanged practical experiences. Arrangements were also made for international regulators to visit a local medical device manufacturing facility to observe how the Taiwanese industry implements international standards. This demonstrates Taiwan’s commitment and achievements in promoting international regulatory harmonization.

In 2025 workshop, participants came from 14 economies, including Singapore, Indonesia, Philippines, Vietnam, Malaysia, Hong Kong, Papua New Guinea, Chile, Peru, Brazil, Cuba, El Salvador, Oman, and Tanzania, fully reflecting Taiwan’s extensive influence in advancing regional cooperation and professional exchange.

As an active APEC member, TFDA continues to drive capacity building and harmonized regulatory frameworks for pharmaceuticals and medical devices. Through the CoE platform, Taiwan is committed to improving submission quality, streamlining reviews, promoting life-cycle regulatory science, and empowering seed instructors—advancing regional convergence and contributing to better public health across the Asia-Pacific.

Each PIF must include 16 items such as product details, ingredient names and concentrations, manufacturing process, toxicological data, stability test reports, and a comprehensive safety assessment, all signed by a qualified safety assessor. This ensures safety through thorough documentation and scientific evaluation.

To facilitate regulatory compliance, the Taiwan Food and Drug Administration (TFDA) offers the Guidelines on the Establishment of Cosmetic Product Information File, along with documents templates for various product types (e.g., sunscreens, hair dyes, perm agent).Online training is also available via the Medical Device and Cosmetic e-Learning Platform (https://mdcel.fda.gov.tw/mooc/explorer.php) to help businesses better understand the applicable requirements and successfully establish their product information files.

JFDA is published online quarterly—in March, June, September, and December—through its dedicated journal website by Elsevier, a globally renowned academic publisher, under commission by the TFDA. The journal features English-language articles in the form of reviews, original research, case reports, and research notes, covering global research in food, pharmaceuticals, toxicology, medical devices, cosmetics, and related fields. According to the latest Journal Citation Reports (JCR), JFDA’s 2024 Impact Factor (IF) is 3.0, placing it in Q2 among SCI journals in both the food science category (88th out of 181 journals) and pharmaceutical science category (138th out of 352 journals). Among all SCI journals from Taiwan across all disciplines, JFDA ranks 8th out of 34.

As of June 2025, JFDA has published a total of 1,928 articles, with submissions originating from 106 countries worldwide. In 2024 alone, the journal’s articles were cited 5,429 times. Since the launch of its dedicated website, JFDA articles have been downloaded 718,101 times across 193 countries. In addition to publishing author-submitted content in each issue, JFDA actively follows current research developments and trends by inviting leading experts to contribute feature articles or guest-edit special issues on trending topics. Notable examples include the 2022 Special Issue on Analysis of Food Toxins: Challenges and Future Trends and the 2024 Special Issue on State-of-the-Art Nanomaterials Revolutionizing the Food and Pharmaceutical Sector, both of which highlight and lead research directions in key or emerging fields.

As of June 13, 2025, JFDA has published Volume 33, Issue 2. The journal features rich and internationally-relevant content, earning wide recognition and attention from professionals across various disciplines. JFDA continues to welcome submissions of high-quality research results from the global scientific community, and encourages readers to visit the official journal website to freely read, download, and cite published articles. (Submission System: https://www.editorialmanager.com/jfda/; Journal Website: https://www.jfda-online.com/journal/).

In 2024, a total of 11 training sessions were conducted, with 253 individuals completing the program. These trained participants leveraged local resources to engage with remote villages, promoting substance abuse prevention through accessible language and interactive approaches. A total of 30 community-based prevention and health education activities were organized, attracting 985 participants and contributing to the development of a protective network for indigenous communities.

For years, the TFDA has been committed to advancing substance abuse prevention across communities, workplaces, and businesses. To further broaden the reach of these efforts, the TFDA has focused on expanding outreach to indigenous tribes in remote areas with limited resources and transportation. By encouraging active participation from local residents, the TFDA continues to foster collective efforts to safeguard community health.

For more information, please visit the “Anti-Drug Resources”website .

The Five Dos:

1. Wash Hands and Ingredients Properly

Thoroughly wash hands with soap under running water before food preparation or consumption. Likewise, all raw ingredients should be rinsed under clean running water to minimize microbial transmission.

2. Select Fresh, High-Quality Ingredients

Prioritize purchasing fresh, perishable items-especially seafood and meat-from reputable and reliable sources. Avoid products that show signs of spoilage or poor storage.

3. Separate Raw and Cooked Foods

Prevent cross-contamination by using designated utensils and cutting boards for raw and cooked items. Store them separately to maintain food safety integrity.

4. Ensure Adequate Cooking

Cook all foods thoroughly to an internal temperature of at least 70°C. Shellfish, such as clams and oysters, should be continuously heated for an additional 3-5 minutes after their shells open to ensure pathogens are eliminated.

5. Refrigerate Promptly and Safely

Cooked food should be refrigerated without delay if not consumed immediately. The traditional practices such as leaving cooked food ambient at room temperature prior to refrigeration is no longer recommended, as it would accelerate bacterial growth during the cooling.

The Two Don’ts:

1. Do Not Drink Untreated Natural Water Sources

Refrain from drinking untreated spring or surface water to prevent infections from pathogens or parasites.

2. Do Not Consume Unknown Wild Foods

Avoid ingesting unidentified wild plants, mushrooms, or animals, as misidentification can result in severe poisoning or fatal outcomes.

The TFDA underscores that food safety is a shared responsibility. Every step from selection and preparation to storage plays a crucial role in preventing foodborne illnesses. Cultivating hygienic habits is the most effective defense against such health risks. For further information and downloadable educational resources on food borne illnesses poisoning prevention, please visit the TFDA’s official website: http://www.fda.gov.tw/TC/site.aspx?sid=1816&r=1633211921.

The focuses of inspection include the compliance with the regulations on governing the Registration of Food Businesses, the regulations on Good Hygiene Practice (GHP), the regulations on the product liability insurance, preserving the related source documents of the raw materials, and the regulations on labeling, as well as the sampling and testing of vegetarian foods. Those who are found to be violations of the Act Governing Food Safety and Sanitation (hereinafter referred to as the “Food Safety Act”) will be punished in accordance with the law.

TFDA calls on all food businesses to practice self-management and comply with the relevant provisions of the Food Safety Act, or else those found to have violated the regulations will be punished according to the law in order to safeguard food safety and sanitation for consumers.  

The topic of the forum is “Transforming Healthcare: How can we maximise the potential of AI while minimising the risks?” Featuring prominent experts from across the globe. We invite you to partake in this event, and participate in the discussions to come.

Register now: https://docs.google.com/forms/d/e/1FAIpQLScr6uYR2RYrD-lJpQAlHskrgnLoIvE7ajNNc7Yq401_qo5UCQ/viewform

The pesticides residues in fruits and vegetables is a prevalent issue of concern in common households. Taiwan’s Food and Drug Administration (FDA) conducts rigorous checks on imported produce to ensure compliance with the Standards for Pesticide Residue Limits in Foods. These products undergo random testing upon arrival, and any that exceed permitted pesticide levels or contain unauthorized substances are either returned or destroyed in accordance with regulations. In cases of repeated violations, inspection frequencies may be increased, and should non-compliance remains rampant, import inspections may be suspended until the exporting country provides a satisfactory explanation and subsequent corrective measures.

The FDA continuously updates its monitoring processes based on the latest pesticide residue standards and publishes information on non-compliant food products on its official website. When purchasing fruits and vegetables, consumers can opt for in season options, choose products from trusted sources, or look for pesticide residue certifications. Additionally, the FDA periodically issues news updates and announcements

(https://www.fda.gov.tw/UnsafeFood/UnsafeFood.aspx) to inform the public about potential risks associated with imported produce and to track non-compliant products.

APEC economies join hands to address the aging trend in the Asia-Pacific region

With the accelerating aging population, changing demographic structure and rising morbidity in Asia-Pacific region, the health of the elderly has become one of the key public health issues today. To promote the development of policies on health diet for the elderly, the “APEC Conference on Policies and Technologies to Promote Healthy Aging with Healthy Diet” was held by the Health Promotion Administration, Ministry of Health and Welfare on March 26, 2025, at the Chang Yung-Fa Foundation International Convention Center. Experts from Canada, Japan, Singapore are invited to share their best practices in nutrition policy development and healthy diet promotion. In addition, the representatives of APEC economies and relevant experts from Taiwan and abroad are invited to exchange their insights. A total of ten economies and more than 300 participants have registered, working together to promote healthy diets for the elderly.

The United Nations advocates for healthy aging, with nutrition as a key element

According to the United Nation Economic and Social Commission for Asia and the Pacific (UNESCAP), the Asia-Pacific region is moving towards an aging population. It is estimated that by 2050, the population over 65 years old will increase to 1 billion; additionally, the UN Decade of Healthy Aging: Plan of Action 2021-2030 emphasizes the importance of health promotion and improving health literacy in achieving healthy aging, and nutrition plays a crucial role. Adopting a healthy diet can not only delay disability, reduce the incidence of non-communicable diseases, but also reduce the medical and financial burdens. This underscores the necessity of promoting age-friendly dietary policies.

Bringing together international industries, governments, academia, and research, to share experiences and future blueprints.

To addressing the challenges of aging society in Asia-Pacific region, this conference focuses on three topics, which are “Nutrition Development Strategy and Policy”, “Explore Healthy Aging Diet with Evidence-based Practice” and “Constructing Age-Friendly Environment and Healthy Diet with AI Applications”. Distinguished speakers from different economies include Ms. Rachel Ngo, Director of Physical Activity and Healthy Ageing Programmes, Health Promotion Board from Singapore, Prof. Koji Miura, Specially Appointed Senior Professor of Fujita Health University from Japan, Prof. Katsuya Iijima, Director of Institute of Gerontology; Professor, Institute for Future Initiatives, The University of Tokyo from Japan and Mr. Yoshimitsu Mori, President of Japan Care Food Conference from Japan. Besides, we are honored to have Prof. Mary R. L’Abbe, Professor Emeritus of the Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto from Canada as the keynote speaker to share the global nutrition issues and challenges. A panel discussion is also be arranged, inviting representatives from Vietnam, Thailand and Malaysia to share policies and strategies in addressing the challenges of aging society.

Toward a super-aged society, creating an age-friendly eating environment

Taiwan entered an aged society in 2018 and has become a super-aging society this year. In response to the health needs of the aging population, the government has adopted various healthy diet policies. In 2023, the Health Promotion Administration, Ministry of Health and Welfare successfully promoted the legislation of the “Nutrition and Healthy Diet Promotion Act” that came into effect in 2024. Through the legislation, the government actively supports the establishment of community nutrition promotion centers and collaborates with the academic and private sectors to develop relevant policies, demonstrating Taiwan’s commitment to promoting healthy diets. Furthermore, to create an age-friendly dietary environment, Taiwan published a “Texture modified Diet Manual” in 2019, combined local dietary habits with adjustments in local ingredients, cutting, and cooking techniques, ensuring that the elderly receive appropriate and balanced nutritional support, thereby enhancing their health and quality of life. Through this conference, Taiwan will share our experiences in nutrition promotion policies, AI applications and healthy diet policies with APEC economies as well as promote dialogue and exchange experiences between economies in order to build a comprehensive age-friendly dietary environment, provide holistic health support for the elderly, and jointly address the challenges and opportunities of an aging society.

Reference: Conference Website of the APEC Conference on Policies and Technologies to Promote Healthy Aging with Healthy Diet: https://www.2025apechpa.org/

Expedited Approval for Orphan Drugs

      To accelerate access to internationally approved orphan drugs, TFDA launched the Orphan Drug Recognition and Expedited Registration Pilot Program in July 2023​. This initiative reduces the approval time from 300 to 240 days for drugs already authorized by the U.S. FDA, EMA, or Japan’s MHLW, allowing quicker market entry. The program streamlines applications by allowing simultaneous orphan drug recognition and market registration, ensuring that patients benefit from global medical advancements without unnecessary delays​.

Key TFDA Initiatives Benefiting Rare Disease Patients

1. Orphan Drug Listings: TFDA updates its orphan drug list regularly. As of December 2024, 140 orphan drugs have been officially recognized, ensuring more treatment options for patients.
2. Recognition and Review: TFDA expedites the approval of internationally recognized orphan drugs, reducing waiting times for patients.
3. Regulatory Updates: TFDA continues to regularly refine orphan drug policies.
4. Transparency in Information: TFDA publishes orphan drug prescription guides and annual reports, offering essential data on drug use, safety monitoring, and treatment outcomes.

Conclusion

     By accelerating approvals, enabling special imports, and continuously refining policies, TFDA is ensuring greater accessibility to orphan drugs. These efforts reflect Taiwan’s strong commitment to supporting rare disease patients, helping them receive timely and effective treatments.

The annual report contains seven chapters. It begins by introducing TFDA, including an overview on its organizational framework, product management policies and prospects, then proceeds with chapters that provide a comprehensive exploration of the management strategies across the four key sectors: food, drugs, medical devices, and cosmetics. Chapter 6, titled “Special Edition,” spotlights notable accomplishments and milestones from 2023, while in chapter 7, titled “Appendix,” significant data are presented through easy-to-read charts.

Aimed to ensure best reading experience possible, this report uses accessible language and charts to highlight essential insights and achievements. Each chapter opens with a concise and engaging summary, accompanied by detailed charts and vibrant illustrations to enhance the reading experience. To find out more about TFDA, the 2024 TFDA Annual Report is now available and free to read on TFDA official website!

E-book link: https://online.fliphtml5.com/crzzi/llel/#p=1
Direct download link: https://gov.tw/Moo

As technology advances and markets globalize, TFDA is committed to digital transformation, aligning with international digital trends. Starting from July 31, 2024 beside hard copy, the TFDA also began issuing digital GMP certificates, which include a digital signature. These digital certificates are encrypted using a digital signature that meets the global Adobe Approved Trust List and Taiwan’s Electronic Signatures Act,  can quickly verify via scanning  QR code or uploading  PDF file to a verification platform, and more than a thousand times verifications have been conducted since plateform launched, clearly demonstrating that the global competitiveness  of Taiwan’s pharmaceutical manufactures has been effectively boosted.

The TFDA emphasizes its commitment to ensuring that the public has access to pharmaceutical products of equivalent to those found in advanced contries, and enhancing the international competitiveness of Taiwan's pharmaceutical manufacturers. TFDA will continue to enhance the  management of pharmaceutical manufacturers, align with the policy of digital governance, and strive to achieve the goal of guaranteeing the safety and quality of pharmaceuticals for the World.

As infants and young children are highly vulnerable, the Taiwan Food and Drug Administration (TFDA) requires manufacturers of infant and young child food products to register under the "Infant and Young Child" category on its "Registration Platform for Food and Medicinal Businesses." This ensures effective monitoring of industry trends and relevant information.

To assist manufacturers in strengthening raw material source management and implementing effective acceptance checks and process controls, the TFDA has initiated guidance programs and provides on-site assistance to help businesses enhance their self-management capabilities. Additionally, training courses on hygiene and safety management for various product types—such as baby rice crackers, canned baby porridge, meat/fish floss for babies, frozen baby porridge, vegetable and fruit puree, dietary supplements, and probiotic powder—are conducted. Related educational resources are also available online for free to support manufacturers' learning.

The TFDA has also set up a dedicated web portal for infant and young child food, where businesses can easily access information on regulations, sanitation standards, labeling, advertising, and health education materials. Manufacturers can visit the TFDA's website to access the dedicated section for infant and young child food here. (https://www.fda.gov.tw/tc/site.aspx?sid=11763&r=922994494)

I. "Five DO's":

1. DO verify the information on the medication bag: Upon receiving medication, confirm that the patient's name, drug name, and quantity on the bag are correct to avoid any mix-ups.
2. DO use proper medication administration techniques: Familiarize yourself with the correct use of different dosage forms and choose the most suitable administration method for your child's age.
3. DO monitor for adverse reactions to children's medications: If your child experiences discomfort after taking medication, promptly consult their doctor.
4. DO keep a record of your child's drug allergies: If your child shows an allergic reaction to a specific drug, document it and inform their doctor or pharmacist during medical visits.
5. DO seek advice from a doctor or pharmacist: If you have any questions before administering medication, always consult a medical professional.

II. "Five DON'Ts":

1. DON'T purchase medication for children without professional advice: Children are not miniature adults. Never give them adult medication or purchase children's medication without consulting a healthcare provider.
2. DON'T discontinue medication or adjust dosage on your own: Don't stop medication due to improved symptoms, especially when using antibiotics. Follow the instructions provided by the doctor or pharmacist and complete the entire course of treatment to avoid developing drug resistance.
3. DON'T store medications carelessly: Keep medications out of children's reach to prevent accidental ingestion. Follow the storage instructions on the package insert or medication bag; don't refrigerate them unnecessarily, as this may cause moisture damage.
4. DON'T use previously unused medications without guidance: Unused liquid medicines or powders can easily deteriorate. Discard any unused portions after each use to avoid self-administration in the future.
5. DON'T take medications with fruit juice or milk: When administering medication, use lukewarm water and avoid mixing with other liquids to prevent potential interactions.

By mastering the "Five DO's and Five DON'Ts" of children's medication, parents can help ensure their children's medication safety. To further promote medication safety education, the TFDA has published several picture books in recent years. Electronic versions are available on the official TFDA website (http://www.fda.gov.tw/TC/siteList.aspx?sid=3690). Parents are encouraged to download and use these resources.

September 25th is designated as "Medication Safety Day" in Taiwan. The TFDA is committed to cultivating correct medication concepts and practices among the public. We remind everyone to consult with medical professionals when seeking treatment or receiving medication to understand the proper way of taking medications and possible side effects, thereby ensuring medication safety for all, especially our children.

The above mentioned three emerging substances of abuse: HHCH, HHC and Etomidate, only Etomidate has anesthetic effect, the other two has no medicinal use; because these emerging substances of abuse may have entered the market and been abused, thus cause harm to our society, as these substances have scientific usage thus enlisted as controlled drugs. Considering scientific use and demands of testing and identification, the four Category 4 narcotics materials were added as schedule 4 controlled drug materials.

From the effective date of the announcement, for institutions and industry that has kept, need to import, export, manufacture, sell, purchase the aforementioned controlled drug items, should apply for controlled drugs registration certificate beforehand, and kept records of drug increase, decrease on a daily bases at business premises, periodical reports shall be made to the local competent health authority and the FDA. Medicinal or educational researchers who have needs of use of the said items, shall apply to FDA before use, and commence dispense the drugs after permission is granted. Whoever when handle the import export, manufacture, selling, purchase and use of the said drugs, should follow the controlled drugs act regulations to avoid violation and punishment.

The "Food Ingredient Integration Query Platform" consolidates the results of ingredient safety evaluations over the past years, frequently asked questions from the public service mailbox, and related directive explanations. The platform provides information on food ingredients that have been evaluated as "suitable for food use" and those that are "not confirmed as safe for food use," offering a more comprehensive collection of food ingredient data. Currently, it encompasses 12 categories with a total of about 1,700 items, and it is continuously updated to provide the latest information.

TFDA recommends reviewing the "Instructions and Notes" at the top of the webpage before searching to fully understand the platform’s purpose and how to use it. When making a search, you can enter Chinese, English, or scientific names as keywords to better confirm whether the platform contains the ingredient in question. When you obtain search results, please click on the hyperlink with the Chinese name of the ingredient to view detailed information about the item, such as recommended usage limits, permitted product types, or cautionary notes. It is essential to follow these limitations and label any relevant warnings accordingly.

TFDA will continue to update the query platform’s data in the future. We encourage all stakeholders to make full use of the platform. For more information, please visit the "Food Ingredient Integration Query Platform" webpage (http://consumer.fda.gov.tw/Food/Material.aspx?nodeID=160), or access it via the FDA website (http://www.fda.gov.tw) by navigating to the main page / Business Areas / Food / Food Business Information Query / "Food Ingredient Integration Query Platform."

Since the “Framework of Cooperation on Medical Products Regulation” was signed by the Taiwan-Japan Relations Association and Japan-Taiwan Exchange Association in November 2013, both sides have alternated hosting Joint Conferences annually for 12 years. This year, representatives from TFDA, MHLW and PMDA will share the latest information on medical product regulations, as well as discuss important topics such as “Improving patient access to innovative drugs and ensuring sustainable supply,” “Regulations on biosimilar products,” and “Latest updates on CADe/CADx medical device review requirements and recent innovations and developments.” The conference, attended by nearly 200 officials and industry representatives from both sides, is being held in person. We hope that through this conference, both sides will gain a better understanding of regulations and create a new blueprint for collaboration between Taiwan and Japan on medical product regulations.

Endorsed by the APEC Regulatory Harmonization Steering Committee (RHSC), the workshop features prominent experts from various countries, including the European Medicines Agency (EMA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), the D. K. Kim International Center for Regulatory Science at the University of Southern California (USC), the Center for Drug Evaluation (CDE), the Asia Partnership Conference of Pharmaceutical Associations (APAC), and the International Research-Based Pharmaceutical Manufacturers Association (IRPMA). These experts share their knowledge on GRM regulations and practical experiences, addressing specific topics such as benefit-risk assessment in regulatory decision-making for market authorization of medicinal products and conducting reviews in regenerative medicine. To foster experience sharing, the workshop also invites regulatory affair related participants from the government, academia, and industries across non-APEC and APEC member economies, including United States, Indonesia, Malaysia, Thailand, the Philippines, Singapore, Vietnam, South Korea and Chinese Taipei. Through the exchange of expertise and knowledge, the workshop aims to enhance cooperation between nations and improve the overall efficiency of medicinal product review and submission processes.

TFDA has long been engaged in APEC RHSC activities. By conducting regulatory training programs, TFDA aim to build capacity, foster international collaboration, and actively promote regulatory convergence and the GRM concept. These efforts continually contribute to improving the quality and efficiency of medicinal product review and submission, ultimately bringing greater health benefits to the public.

The inspection project focuses on the registration requirements for food businesses, the Regulation on Good Hygiene Practice for Food (GHP), product liability insurance, self-management, and product traceability. Additionally, chocolate products will be checked for labeling and hygiene compliance. Violations of the Act Governing Food Safety and Sanitation will be punished by law.

TFDA strongly recommends that food businesses effectively implement self-management practices in accordance with the Act Governing Food Safety and Sanitation to ensure the safety and sanitation of chocolate products and protect consumers’ health.

The Journal of Food and Drug Analysis (JFDA), an international scientific SCI journal published by the Taiwan Food and Drug Administration (TFDA), has attained an Impact Factor (IF) of 2.6 in the year 2023. This milestone solidifies JFDA's position as one of the most influential international journals in the field of food science and pharmaceuticals. Scholars and experts worldwide are welcome to cite, subscribe, and publish their research in JFDA.

  As an online publication, JFDA encompasses comprehensive reviews and original articles in English, focusing on diverse areas such as food, medicine, toxicology, medical devices, cosmetics. According to the Journal Citation Report of 2024, JFDA reached an Impact Factor (IF) of 2.6 in 2023, ranking in Q2 among SCI journals of both food science and pharmaceuticals worldwide (food science 85/173; pharmaceuticals 173/354). The ranking of JFDA among all the domestic SCI journal was 14/82.

  Furthermore, JFDA is dedicated to publishing special issues on specific themes and emerging fields Notably, the journal released the Special Issue on "Novel Approaches of Nanotechnology in Food Science" in 2020, followed by the Special Issue on "Analysis of Food Toxins: Challenges and Future Trends" in 2022. These endeavors enable JFDA to highlight and lead essential research and development trends in significant domains.

  With authors hailing from 106 countries, JFDA has collected over 5,000 citations to date. Readers from 199 countries have accessed the JFDA official website, with journal articles being downloaded a remarkable 465,658 times. The publication's diverse and international content has garnered immense popularity and acclaim within academia. In line with the commitment to fostering knowledge exchange, JFDA cordially welcomes all interested parties to submit their research findings and read, download, and cite the publications free of charge via the official website (JFDA official website: https://www.jfda-online.com/journal/; JFDA Editorial Manager submission and review system: https://www.editorialmanager.com/jfda/).

The Asia-Pacific Academic Consortium for Public Health (APACPH), established in 1984, is the most prestigious public health professional non-profit academic international organization in the Asia-Pacific region, serving as a vital think tank for the health departments of various countries. In 2017, the Taiwan Health Promotion Administration and APACPH jointly established the Collaborating Centres for Health Promotion (APACPH CCHP) with the primary goal of enhancing the core capacities of health promotion among senior public health professionals in the Asia-Pacific region. This initiative aims to increase Taiwan's visibility in the Asia-Pacific region and the New Southbound Policy countries. The CCHP Director is Dr. Hung-Yi Chiou, who is also the Director of Institute of Population Health Sciences at the National Health Research Institute. The Chief Executive Officer (CEO) is Dr. Ya-Wen Chiu, a Research Fellow at the National Health Research Institutes. With long-term support from the Taiwan Health Promotion Administration, CCHP has organized nearly 25 international conferences, forums, and educational training workshops both domestically and abroad. It has developed trend studies focusing on non-communicable diseases, strengthened the resilience of health systems in Taiwan and partner countries, and integrated preventive measures to enhance the overall health level of the region.

International exchange, enhancing global health

On the first day (August 6th), the representatives and experts from the National University of Singapore, the University of Tokyo, the Korea Health Promotion Institute, Yonsei University, and the National Taiwan University College of Medicine, sharing policies and case studies addressing the increasing prevalence of non-communicable diseases in their countries. In particular, cancer has become a global health issue that poses significant burdens on national healthcare systems, human resources, and finance. The workshop, therefore, put specific emphasis on lung cancer prevention strategies and health promotion. The participants shared how their countries are utilizing cutting-edge technology and training to provide earlier diagnosis and treatment and improve the patient’s survival rate and quality of life. Dr. Masamine Jimba from the University of Tokyo presented unique insights and practical examples on the application of AI in healthcare, while Dr. Yun Chung Chang from the National Taiwan University College of Medicine shared Taiwan's strategies and achievements in promoting early lung cancer screening. Their insightful discussions provided the audience with valuable experience and contributed to the promotion of health and well-being in the Asia-Pacific region.

To enhance the comprehensive research capabilities of Taiwan's health promotion personnel, on the second day (August 7th) of the workshop, we will invite seed teachers from seven universities in Taiwan and top international speakers for in-depth discussions. They will share design breakthroughs in case studies, focusing on the important contemporary issue of obesity. Rich exchanges and opportunities for international collaboration is gained through roundtable discussions, marking a perfect end to this year's workshop. This workshop not only provides an excellent platform for Taiwan's healthcare professionals to connect with the international community but also aims to increase opportunities for multilateral cooperation in the future.

Director-General Chao-Chun Wu of the Taiwan Health Promotion Administration stated that HPA is committed to the prevention and treatment of non-communicable diseases and integrates the strength of professional groups to implement the vision of Healthy Taiwan. The sharing and innovative insights given by scholars and experts from four countries at this workshop provided an enlightening discussion. He welcomed further international programs and stressed that the event connected the Asia-Pacific region with shared values and took a significant step toward the parity of health across this region, for the good of enhancing global health.

ICCR, comprised of a voluntary international group of regulatory bodies, aims to harmonize global cosmetics regulations to ensure consumer safety. The annual meeting included representatives from 12 countries including the European Union, the United States, Canada, Japan, Brazil, South Korea, and Israel, totaling 50 participants, who extensively discussed collaborative efforts and developments in cosmetics regulations around the globe. Additionally, the symposium featured four speakers representing cosmetics associations from Taiwan, Japan, and Europe, who shared insights on topics such as green factories and climate-resilient cosmetics, exploring sustainable perspectives and global trends in the industry. More than 300 representatives and professionals from the cosmetics industry, both domestic and international, participated.  The participants expressed satisfaction with the outcomes and anticipate future gatherings in Taiwan.

Given the rapidly evolving global trends in cosmetics management, Taiwan is resolute in our determination to be on par with the rest of the world. The TFDA will continue to collaborate with cosmetics regulatory bodies overseas, playing a crucial role in the harmonization of cosmetics regulations on an international level. Simultaneously, TFDA will work alongside local industry to showcase Taiwan's vibrant cosmetics industry and its international competitiveness to the world.

The GMP requirements for cosmetics in Taiwan are based on the international standard ISO 22716 to align with global standards. Furthermore, the manufacturing sites for baby, lip, eye, non-medicinal toothpaste, and mouthwash cosmetics are required to comply with cosmetics GMP on July 1, 2025. And all cosmetic manufacturing sites must fully comply with GMP since July 1st of 2025 to provide safe and high-quality cosmetic products to the public.

This event echoes the theme of this year's International Nurses Day: "Our Nurses. Our Future. The Economic Power of Care." The World Health Organization (WHO) has pointed out that investing in nursing workforce and retention is a key element in increasing the coverage of public health and a pivotal strategy for achieving national sustainable development goals. During the forum, Director-General Tsay Shwu-Feng of the MOHW Department of Nursing and Health Care will deliver a keynote speech with three outlines, "Narrating Nursing Workforce with Data," "Visionary Investment in Nursing Policies," and "Transforming Nursing Through Action," emphasizing Taiwan's capability to contribute and expressing solidarity in international nursing development and sustainable global health care.

The WHO is advocating for the development of innovative nursing models focused on preventive and holistic care, aligned with the WHO Traditional Medicine Strategy 2014-2023, suggesting the integration of traditional and complementary therapies into global health care systems. Current research indicates a significant increase in the utilization and attention to non-pharmacological care measures and naturopathic medicine in European countries. However, healthcare professionals often lack awareness in this field, while the public expects healthcare providers to offer consultations on non-pharmacological care measures and naturopathic therapies. To strengthen the knowledge, attitudes, and skills of European nurses in evidence-based non-pharmacological integrative care measures and naturopathic medicine, the European Union completed a four-year project (2019-2023) to develop an integrated nursing education curriculum and competency map. Additionally, teaching manuals for nursing instructors were developed, and the materials have been shared and promoted in over 200 nursing schools across the European Union, with the aim of facilitating self-care among nursing professionals and providing better healthcare services to the public.

    As one of the founding members of the Global Cross-Border Privacy Rules (CBPR) Forum, Chinese Taipei endeavors to promote trusted data flows and to eliminate unnecessary barriers in digital trade. As global digitalization continues to accelerate, demand for international data transmission has increased sharply. Personal data infringement incidents often involve overseas factors, requiring cooperation between jurisdictions from different territories to effectively combat illegal activities and reduce infringement. In order to achieve the goal, the Global CBPR Forum established the Global CAPE in October, 2023 and invited Privacy Enforcement Authorities (PEAs), not limited to those of Forum members, to facilitate cross-border cooperation around the world.

    In addition to Chinese Taipei, United States, Japan, Canada, the United Kingdom, South Korea, the Philippines, Singapore, Mexico, Dubai International Financial Center, and Bermuda join Global CAPE. This opens up opportunities for Taiwan’s PEAs to work with overseas  partners on cross-border enforcement related to privacy complaints, data protection, data sharing, and professional exchanges. Such collaboration will enhance the protection of privacy information, align with international legal standards and practical trends, foster cross-border digital trade and boost Taiwan's digital economy.

    TFDA spares no effort in enforcing the anti-drug work, faced with the chal-lenge of endless emerging drugs, actively implements the “New Generation Anti-drug Strategy” of the Executive Yuan. Portable Raman spectrometers are used for boarder inspection of active pharmaceutical ingredients to keep drug outside of the boarder, testing resources of both government and non-government laboratories are integrated to maximize testing capability to stop drug flow in the country; thus en-sure the health of the people. However, drug appearances vary widely, transformed from powder and pills as we used to know to look like snacks and drinks such as coffee bags, tea bags, jelly, candy or plum slices, also cute patterns may be printed on the package to attract people’s attention, let down ones guard thus leading to misuse. As drugs harm to health are well known, TFDA calls for people to stay vig-ilant and on guard at all time to protect oneself, be brave to refuse food and drink from unknown sources, and never use out of curiosity or encouragement by others.

    More drug abuse and hazard prevention information can be found at TFDA an-tidrug resources website (http://www.fda.gov.tw/TC/site.aspx?sid=10070), or you can call the consultation hotline of local government Drug Abuse Prevention Cen-ters at 0800-770-885.

    Some additives of medical masks, such as some azo colorants, formaldehyde and migratable fluorescent substances, are reported to be hazardous to human health. To minimize the impact of such additives to human health, TFDA requires applicants who apply for the registration of colored or dyed medical masks to provide relevant evidence to prove that the products to be registered meet the quality requirements for colored or dyed medical masks of CNS 14774. 

    Moreover, according to the amended “Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration”in 2023, if the applicants submit the medical masks labeled/claimed to meet performance requirements of specific international or national standards, such as N95 or FFP2, they should submit the test reports or certificates from the competent authorities, qualified laboratory or international organizations, to prove their claims. 

    The amendments helped to make regulatory management of medical masks more comprehensive and it is recommended that medical device manufacturers or applicants understand relevant requirements before applying to facilitate product development and subsequent registration procedures.

    Food items for personal use and non-commercial purposes that are brought in from overseas and meet the specified criteria could be approved for release by the customs department without import inspection by TFDA.

1.The cost of an individual food item (excluding capsules and tablets) must not exceed $1,000 USD and shall weigh no more than 6 kilograms.

2.For a single import, the quantity of each capsule or tablet prod-uct must not exceed 12 bottles (including boxes, cans, packs, and bags), with a total not exceeding 36 bottles (limited to the original packaging of boxes, cans, packs, and bags).

    The above-mentioned imported products for personal use without imported inspection shall not be circulated for sale. Sell-ing such products is considered a violation of Article 30, Para-graph 1 of the Food Safety and Sanitation Act and is subject to a fine ranging from NT$30,000 to NT$3,000,000, as stipulated in Article 47 of the same Act. In addition, specific foods such as meat, fish, dairy, and plants must conform to the quarantine re-quirements set by the Ministry of Agriculture and regulations of other government department.

    ICMRA is a voluntary-basis, executive level, international and non-political coalition of head of medicines regulatory authorities. ICMRA was established in 2013 and aims to support enhanced communication, information sharing, crisis response and address global regulatory science issues. ICMRA is currently consisted of 24 Full members (i.e., US FDA, EMA, MHLW/PMDA, MFDS, Health Canada, etc) and 15 Associate members (i.e., DKMA, ANMAT, SFDA, etc). The coalition now focus on issues related to innovation, Pharmaceutical Quality Knowledge Management System (PQKMS), public health emergency clinical trials, RWE and vaccine pharmacovigilance and jointly produce reflection paper and host workshops. 

    In the future, TFDA will actively participate in all the ICMRA working groups and initiatives to deep dive into learning the trends of the current global regulatory issues and exchanging information on the health policy with other medicines regulatory authorities. Through joining the ICMRA will help TFDA better cope with all the challenges, construct the regulatory environment that harmonize with international standards and thus achieve the goal of continuous international collaboration.

The application of TCP III has officially announced since 2019 and is remain open to any EU MDR and/or IVDR designated Notified Body who is interested in becoming a TCP III partner. The implementation of TCP III assists medical device manufacturers in both Taiwan and the EU in complying with the regulations for medical devices on both sides. Adhering to the principles of equality and reciprocity, it provide favourable to medical device manufacturers from both Taiwan and the EU. By taking advantage of international cooperation and sharing inspection resources, it aims to strengthen regulatory collaboration between Taiwan and the EU.

The annual report contains seven chapters. It begins with an introduction of the organization, overview of product management and prospects of TFDA, followed by detailed chapters that elaborate on the management of the four major sectors: food, drugs, medical devices, and cosmetics. In chapter 6, titled “Special Edition”, significant breakthroughs and achievements in 2022 are highlighted, while in chapter 7, titled “Appendix”, data and information are presented in charts.

To know more about the rich content, you can now read and download 2023 TFDA Annual Report for free on TFDA official website!

E-book link: https://gov.tw/dYR

Direct download link: https://gov.tw/Cxf

Because infant formula and follow-up infant formula may be used as a breastmilk substitute which satisfies the nutritional requirements of infants and supplement the nutritional needs for the growth and development of older infants, a stricter measure of food safety management is taken in Taiwan. Additional labeling requirements for infant formula and follow up infant formula are stipulated in “Regulations Governing the Labeling which shall be labeled of Infant and Follow-up Formula” (hereafter, the Regulations) and related regulations. Required information on the label of formula product is as follows: infant's iron needs, storage and preparation instructions, feeding guide, the characteristics of the products and applicable users for products for special medical purposes, and warning statements about preparation and use and the addition of complementary foods. Additionally, the recognized label of “woman with baby” with the phrase “Breast milk is the best food for your baby” and “Ministry of Health and Welfare cares for you” shall appear on the product label. Phrases like “humanized”, “maternalized” or other similar phrases suggesting superiority to breast milk shall not be labeled.

The full text of the Regulations is available on the TFDA website (http://consumer.fda.gov.tw/Law/Detail.aspx?nodeID=518&lawid=829)

    The Taiwan Food and Drug Administration(TFDA)submitted its application to be included in the list of third countries on 8 December 2021. Following a review of the relevant documents, the European Commission conducted an on-site audit from April 20 to 27 this year. The audit team, consisting of one auditor from the EC and one from an EU member state, engaged in a comprehensive assessment, which included documentary review and personnel interviews with TFDA to grasp the design of the regulatory control system in place and scrutinize its actual implementation. The audit team also visited two API manufacturers in Taiwan to witness their inspection performance. Impressed by TFDA's performance, the audit team reached a positive conclusion, affirming that the Taiwanese system can be considered equivalent to the EU. After several months of internal procedures, the European Union officially announced on 10 November that Taiwan has been included in the list of third countries.

    According to EC regulations, starting from July 2013, imported APIs from countries outside the EU must be accompanied by a "Written Confirmation" from the competent authorities of the exporting third countries. This confirmation verifies that the APIs were manufactured under control and enforcement of good 
manufacturing practices equivalent to those in the EU. The only exception is for APIs imported from countries already on the list of third countries. Presently, nine countries, including Taiwan, Canada, South Korea, Australia, Brazil, Israel, Japan, Switzerland, and the US, have successfully been added to this list. 

    IMDRF is an international organization that was established in 2011. There are currently 11 MC Members from the regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan, Russia, Singapore, South Korea, United Kingdom, and the United States of America, who have come together to strategically accelerate international medical device regulatory convergence. At this time, the organization has 7 working groups that focus on adverse event terminology, artificial intelligence/machine learning-enabled medical devices, good regulatory review practices, personalized medical devices, quality management systems, regulated product submission, and software as a medical device. They develop harmonized regulatory guidances for all stakeholders to follow.

    In the future through this affiliate membership, TFDA can participate in MC meetings to find out the latest medical device regulatory strategies and trends, as well as join working groups to have information exchange on technical topics with other regulators. This may strengthen TFDA’s medical device regulatory system, help it meet emerging technical challenges that are increasingly diverse, ensure protection of public health and safety, and continue to maintain the goal of internationalization for its medical device regulation.

In recent years, with the rapid advancement of smart technologies such as artificial intelligence, cloud computing, and mobile devices, the medical field has seen remarkable progress. These technologies have found innovative applications in various aspects, including drug development, precision medicine, healthcare, and pharmaceutical services. They have not only enhanced the safety and efficacy of medications and medical equipment but have also accelerated the delivery of healthcare services, enabling patients to receive the treatment and care they need more efficiently. This international pharmaceutical conference aimed to share the policy initiatives and clinical experiences of different countries in using technology in the field of medicine. It provided a platform for professionals from around the world to exchange knowledge and ideas, with the hope of bringing new perspectives and developments to the pharmaceutical industry and pharmaceutical services.

    For the workshop, TFDA has invited experts and scholars from Japan, Korea, Vietnam, Malaysia, Academia Sinica, and TFDA. They will share their knowledge of analytical techniques, surveillance and related experiences for detecting biotechnology-derived crops such as genetically modified food. The workshop is attended by roughly 100 domestic and international professionals and researchers from government organizations, academic institutions, and industry. The workshop aims to provide a rich learning and knowledge-sharing environment that will benefit all attendees significantly.

    TFDA is committed to ensuring a safe food environment for the public. In addition to legislation, enhancing source control, and inspections, TFDA works on analytical techniques to enable evidence-based administrative enforcement. Given the rapid breakthroughs in analytical technologies and new methodologies, the workshop contributes to the advancement of domestic analytical techniques and their alignment with international best practices, hence facilitating opportunities for international cooperation and communication between Chinese Taipei and other Asia-Pacific economies.

Since the “Framework of the Cooperation on the Medical Products Regulation” was signed by Taiwan-Japan Relations Association and Japan-Taiwan Exchange Association in November 2013, both sides have hosted Annual Joint Conferences in alternating turns for eleven years. This year, the representatives from TFDA, MHLW and PMDA share the latest information on medical products regulations, as well as other important topics such as RWD/RWE for Accelerating Clinical Development, New Drug Review Cooperation between Japan and Taiwan, Regenerative Medicinal Products Regulation, Cybersecurity for Medical Devices and updates on medical devices regulation. The conference will also be streamed live for virtual attendees via Webex. Both officials and industries will join the conference with about 800 people participating. We hope that through this conference, the industry from both sides will gain a better understanding of the regulations and create a new blueprint for the collaboration between Taiwan and Japan on medical products regulations.

    To foster the quality and accessibility of community pharmacies, the Taiwan Food and Drug Administration (TFDA) has launched a series of strategic plans in recent years:

Revised Regulations on Good Practices for Drug Dispensation

    The updated regulations mandate community pharmacies to retain source evidence and relevant documents of drugs to prevent counterfeit or misbranded drugs from entering the supply chain. It also imposes detailed requirements on drug storage conditions and recording of environmental conditions (e.g., temperature), ensuring consistent drug quality. New articles have also been introduced to guide compounding (changing the original dosage form or creating a new product), allowing pharmacists to fulfill their skills further. 

Promotion of Structured Electronic Package Inserts

    TFDA actively promotes the digitization and structuring of drug package inserts. By transforming package inserts into structured formats, the information on package inserts can be transmitted and utilized more smoothly and extensively. Furthermore, a drug package inserts inquiry platform was established to facilitate public access to drug information.

Enhancing Barrier-Free Environments in Community Pharmacies

    TFDA emphasizes creating barrier-free environments, holding meetings with Disabled people’s organizations (DPO) to understand their needs and conduct educational training programs to enhance pharmacies' understanding of accessibility. For more people to access medication and services in community pharmacies, TFDA continually encourages community pharmacies to voluntarily report as barrier-free establishments. Additionally, an online map for inquiries about accessible facility pharmacies aids individuals with disabilities in locating suitable pharmacies.

Diverse Pharmaceutical Services

    TFDA advocates for a broader array of pharmaceutical services. Notably, during the pandemic, many pharmacies initiated home delivery services. Recognizing the mobility challenges faced by some individuals, TFDA maintains its promotion of the service to ease the process of acquiring medications. Furthermore, community pharmacies now offer integrated medication management, medication adherence promotion, and drug consultation services. It is hoped that community pharmacy pharmacists can offer more comprehensive and professional services to meet the diverse health needs of the public.

    Looking forward, TFDA will sustain collaborations with relevant stakeholders and experts, ensuring the effective and continuous execution of these initiatives while also developing new ones. TFDA also encourages the public to avail themselves of the manifold services offered by community pharmacies, championing their endeavors in this field.

The workshop will tackle essential topics such as digital health technology development, efficient data management, and successful public-private healthcare collaborations. Additionally, renowned institutions like Kaohsiung Medical University Chung-Ho Memorial Hospital, Chang Gung Memorial Hospital in Linkou, China Medical University Hospital, and La Vida Tech. will showcase digital health-themed exhibitions.

With the growing adoption of cloud technology, mobile networks, and various mobile devices, coupled with the impact of the COVID-19 pandemic, the use of information technology in healthcare has significantly increased. Taiwan's healthcare and technology sectors have embraced this global trend in digital healthcare development. This workshop will explore post-pandemic digital health policies, innovative government service models, health data management principles, and practical healthcare case studies.

APEC, an important international organization with Taiwan's formal participation, plays a crucial role. The Director-General of the NHIA has actively engaged with the APEC Health Working Group for years, working to host meaningful events in Taiwan. This time, the NHIA introduced "Digital Healthcare Public-Private Collaboration" as a central theme, receiving substantial support from APEC member economies.

Through this workshop, the NHIA aims to strengthen collaboration between the public and private sectors, enhancing the adaptive capabilities of healthcare systems within APEC member economies to address health challenges effectively. Simultaneously, the NHIA seeks to enhance cooperation and policy exchange between Taiwan and diverse APEC member nations. For detailed information about the workshop, please visit the conference website(https://www.2023apecNHI.org).

GHWP is an international voluntary organization aiming at global convergence and harmonization of medical device regulations. Toward the goal, it promotes an agile and fit-for purpose regulatory model for medical devices through a series of guidance documents, developed by its TC working groups. However, as related technologies develop rapidly and regulations under different jurisdictions are updated from time to time, GHWP guidance documents need to be revised to reflect the current regulatory landscape. The two joint work items addressed in this meeting are both revising existing guidance documents, originally prepared collaboratively by the three attending WGs. The first revisited document is titled “Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU),” whose content was enriched and references updated in this revision. The other work item is to develop a document regarding the management of changes made to a registered medical device, by merging existing related GHWP documents. In the meeting, attendees from the three WGs had lively discussions and contributed their respective expertise to the revising work, producing fruitful outcomes when the meeting adjourned.

As a member of GHWP since its establishment, Taiwan has been dedicating to harmonization in medical device regulations by actively participating the organization’s activities. Taiwan FDA had been the Chair of WG2 since 2012 and was elected as Chair of WG3 in 2023, and has received worldwide positive recognition for all the efforts devoted. Taking the leading role and the initiative, Taiwan FDA hosted this first physical joint WG meeting to declare that the operation of the organization had recovered from the challenges posed by the pandemic. It also thanks all the honorable participants for attending the meeting and for their valuable opinions, which made the meeting itself and its outcomes possible. Taiwan FDA will continue to contribute to promoting medical device regulation harmonization, such that new medical technologies can be promptly introduced with emphases on the safety and performance, to benefit possible users worldwide.

    This workshop is endorsed by the APEC Regulatory Harmonization Steering Committee (RHSC). TFDA has invited experts from U.S. FDA, EMA, PMDA, International Center for Regulatory Science (University of Southern California), CDE and IRPMA etc., to share with the trainees about the concept, principles and cases of implementing GRM. To foster the experience sharing with each other, TFDA also invited reviewers and applicants from the USA, Malaysia, Philippines, Singapore, Indonesia, Thailand, Vietnam, Papua New Guinea, Pakistan, Botswana and Taiwan to participate in the workshop.

    TFDA has been actively engaging in the APEC RHSC activities. Since 2016, 70-110 trainees have been trained through the workshop annually. Through the workshop, it will not only contribute to promote the concept of GRM, but also improve the efficiency of drug review and submission. TFDA will continue to host the GRM workshops and provide training programs to strengthen the capacity building and international collaboration for achieving the goal of well-being and health for all.

    TFDA conducts the Center of Excellence training on a continuous basis since 2019, in order to achieve Taiwan’s goal of promoting medical device regulatory convergence, capacity building, and international cooperation.

To further strengthen health cooperation, with joint efforts of the Ministry of Health and Welfare (MOHW) and the Ministry of Foreign Affairs (MOFA), an MOU on health cooperation between Taiwan and the Czech Republic is signed by Representative      Liang-Ruey Ke of Taipei Economic and Cultural Office in Prague and Representative David Steinke of Czech Economic and Cultural Office in Taipei on July 14, 2023, witnessed by Minister Jui-Yuan Hsueh of MOHW, Deputy Minister Chun Lee of MOFA and Minister Vlastimil Válek of the Ministry of Health of the Czech Republic. This MOU will be executed by Taiwan MOHW and the Ministry of Health of the Czech Republic. Areas of cooperation include global health security, digital health, medicines and medical devices, and management of hospitals etc. Under the framework of the MOU, substantive cooperation activities are conducted by cooperative programs, personnel exchange and training, bilateral visits, workshops, and conferences as well as establishment of contact points. This MOU aims to enhance substantive cooperation and continue to promote the health and well-being of the people in Taiwan and the Czech Republic.

    This MOU paves the way for bilateral health cooperation. Areas of cooperation include pandemic preparedness, digital health, health insurance, mental health, and healthy ageing. Under the framework of the MOU, substantive cooperation activities include information sharing and exchange, bilateral visits, joint workshops and meetings. These activities will also be carried out based on an annual work plan by both sides. This MOU aims to enhance cooperation and continued work together on global health.

    Price of single foods (not include capsules and tablets) do not over than 1,000 USD and weight less 6 kg. The quantity for each capsule and tablet product type may not exceed 12 bottles (include：boxes, cans, packs, bags), the total may not exceed 36 bottles (limited to original packaging in boxes, cans, packs, bags) for single import. Follow above of the rule do not need to apply for inspection with the TFDA, the Customs department must approve for release. However, items for personal use are exempted from import inspection are not to be sold. Anyone who sells the products shall be deemed in violation of paragraphs 1 and 3 of Article 30 of the Act Governing Food and Safety Sanitation. A fine between NT$30,000 and NT$3,000,000 shall be imposed in accordance with Article 47 of the same act. In addition, application for inspection exemption may be suspended for one year in accordance with paragraph 2 of Article 51. Besides, some of these foods (meat, fish, milk, plant etc.) shall meet quarantine requirements of Council of Agriculture, Executive Yuan and regulations of other government departments.

    TFDA would also like to remind the public that dietary supplements (capsules, tablets) cannot replace drugs. In the case of any physical discomfort, the public should seek proper medical attention to avoid delayed treatment. Before special populations (such as children, pregnant women, chronic disease patients) consume dietary supplement, they should seek the advice of physicians, nutritionists, and other professional medical staff. The recommended intake amount, warnings and precautions on the product label should be read before consumption. Do not overconsume on the supplement. If any symptoms of discomfort appear after consumption, please immediately stop taking the supplement and seek medical attention as soon as possible.

The TFDA emphasizes its commitment to ensuring that the public has access to pharmaceutical products of equivalent quality to those found in advanced countries. It will continue to enhance the management of foreign pharmaceutical manufacturers, monitor international non-compliance with GMP issues and alerts, and take immediate actions to ensure the safety of medication for the Taiwanese public. The TFDA strives to achieve the goal of guaranteeing the safety and quality of pharmaceuticals.

    This project will focus on compliance with the Registration of Food Businesses, Regulations on Good Hygiene Practice for Food (GHP), Regulations on Food Safety Control System (HACCP), and other regulations, as well as the legality of raw materials and product labeling. Meanwhile, raw eggs will be sampled and tested for animal drugs and pesticide residues, and finished liquid eggs will be sampled and tested in accordance with the Sanitation Standard for Microorganisms in Foods.

    TFDA urges the food industry to implement self-regulation and comply with the relevant provisions of the Act Governing Food Safety and Sanitation to ensure the health and safety and quality of liquid egg products. Violations will be dealt with in accordance with the law for the protection of food hygiene and consumer safety.

    Cancer remains the leading cause of death in Taiwan, and its incidence continues to rise. The rapidly evolving treatment methods for cancer have put a significant strain on the limited resources of the National Health Insurance system. To expedite access to advanced cancer drugs while also considering the sustainability of the health insurance system, Director-General Chung-Liang Shih of the NHIA, Director-General Chao-Chun Wu of the Health Promotion Administration, and CEO Shyr-Yi Lin of the Center for Drug Evaluation (CDE) visited NICE and officials from the National Health Service (NHS) in the UK.

    During the visit, discussions were held on various topics, including the operation of the Innovative Medicines Fund (IMF) and the Cancer Drugs Fund (CDF), HTA

    methodology, and diverse financial management mechanisms. On May 18, NHIA Director-General Chung-Liang Shih, CDE CEO Shyr-Yi Lin, and NICE signed a partnership agreement, solidifying their commitment to deepen information exchange and personnel training. The collaboration aims to enhance the evaluation and inclusion of new drugs in the health insurance system, providing a more comprehensive cancer treatment guarantee to the population.

    The NICE is the independent body responsible for driving improvement and excellence in the health and social care system. It develops guidance, standards and information on high-quality health and social care. NICE also advises on ways to promote healthy living and prevents ill health. 

    NICE’s aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation. 

    NICE’s products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services. This visit aimed to learn how to effectively utilize HTA techniques within the constraints of limited resources, ensuring timely access to breakthrough new drugs. Additionally, the collection and assessment of real-world data will aid in phasing out drugs that lack proof of cost-effectiveness at the time of initial assessment, ensuring that resources are focused where they are most needed. This partnership agreement provides a solution to the challenges posed by expensive new drugs with uncertain outcomes.

    Director-General Chung-Liang Shih expressed during the meeting, "Today, it is my great honor to lead the Taiwan delegation from the Ministry of Health and Welfare to visit NICE, which has a 24-year-long history, and learn about the renowned Cancer Drugs Fund system. Signing a partnership agreement on behalf of the NHIA with NICE is an important milestone in the 28-year history of Taiwan's National Health Insurance development." NICE also have MOUs with Canada's CADTH and Australia's PBAC, both being top international HTA institutions, which demonstrates the recognition of the NHIA's big data management and the impact of the CDE in HTA.

    “We are delighted to support Taiwan's ambitions to advance their HTA system and are keen to share our experience in the UK with them. This agreement provides us with an excellent opportunity to exchange ideas and find common solutions to HTA-related challenges that will translate into benefits for patients in both our countries.” Pilar Pinilla-Dominguez, NICE International Associate Director.

    Through this agreement, the NHIA and NICE will focus on personnel training and technical discussions in HTA. The collaboration will provide an opportunity to learn about the latest trends and methods in cutting edge HTA skills. This will include comprehensive exchanges on processes and methods for developing HTA evaluations of new drugs, the application of real-world data, and the financial operation of the innovative medicines funds and cancer drugs funds. The NHIA is eager to share its advancements in big data management and the utilization of artificial intelligence with NICE, fostering a mutually beneficial partnership and promoting the effective implementation of the partnership agreement.

    For nationals who have received treatment abroad and returned to Taiwan with controlled drugs, according to the customs declaration instructions, the medicine is limited to treating illness of the passenger his/her self, a medical institution certificate is required, the amount cannot exceed that on the prescription, and the medicine should be carried, send by mail or express delivery is not allowed.

    Controlled drugs include addictive narcotics and psychotropic drugs (e.g., sleeping pills) which are strictly regulated by all countries in the world, commonly used sedative hypnotics such as zopidem, triazolam, and flunitrazepam, as well as addictive narcotics of morphine and fentanyl are all controlled drugs, and can only be used for medical and scientific purposes. If the source of the controlled drugs is unknown or used illegally, that would be regarded as illegal drugs and regulated by the Narcotics Hazard Prevention Act.

    TFDA reiterates its call to nationals travel abroad for tourism or business, to also carry a diagnostic certificate or a copy of prescription from the attending physician if carrying medicines for personal use. If the medicines belong to schedule 1 to 3 controlled drugs (the controlled drugs list can be found on TFDA website (http://www.fda.gov.tw), you can send to TFDA a declaration and medical diagnostic certificate to apply for a certification document according to article 18 of the Enforcement Rules for the Controlled Drugs Act. Before travel abroad, you can also check at Bureau of Consular Affairs, Ministry of Foreign Affairs’ website at (http://www.boca.gov.tw), to find out if there are any particular regulations to avoid violating the law of the country of entry.

Health Minister Jui-Yuan Hsueh, urged all people to cherish their health and follow a healthy lifestyle, while also caring for their family and friends to promote correct health concepts. Minister Hsueh emphasized, "In the shadow of the past three years of the pandemic, Taiwan has already proven to the world that it can stand shoulder to shoulder with other countries to fight the epidemic. Therefore, Taiwan cannot be absent in any world health alliance, including WHO."

Chung-Liang Shih, Director-General of the National Health Insurance Administration, also stated that this year marks the 28th anniversary of the implementation of National Health Insurance (NHI), and Taiwan's NHI has reached 100%, providing every citizen with high-quality medical care services from womb to tomb, from preventive care to long-term care. Director-General Shih mentioned that "for many countries, Taiwan's health insurance system is a model for implementing the World Health Organization's call for universal health coverage." Providing comprehensive medical care for all citizens, leaving no one behind, makes diseases no longer the main cause of the wealth gap.

The National Health Insurance (NHI) in Taiwan covers a wide range of medical services, including general illnesses, rare diseases, cancer, and advanced medical technologies such as CT scans, MRI scans, and robotic surgeries. The NHI also provides integrated care for different patient groups, such as chronic disease management and home healthcare, to achieve the goal of whole-person care. Taiwan was the first country in the world to implement a universal B hepatitis vaccine policy, and since 2017, it has included oral medication for C hepatitis in the NHI coverage, with the aim of eliminating 80% of C hepatitis cases by 2030 in response to WHO's call. In particular, during the outbreak of the COVID-19 pandemic, Taiwan's comprehensive insurance system and high-quality medical system effectively contained the spread of the virus, allowing communities to function normally and providing valuable lessons for other countries.

Taiwan supports the United Nations' "2030 Sustainable Development Agenda" passed in September 2015, as well as the World Health Organization's call for countries to achieve universal health coverage by 2030. Taiwan's National Health Insurance system provides a valuable example for the world to learn from and reference. Director General Shih Chung-liang also pointed out that this year, the vision of the National Health Insurance Administration, SDGS, echoes the Sustainable Development Goals of the United Nations. SDGS stands for System integration, Digital technology, Great partnership, and Sound finance, which are the main directions for promoting future health care.

The National Health Insurance Administration recognizes the importance of collaborating and exchanging with the global international community. In the future, we will actively align with international health policies, create a whole-person and whole-process health care, and continue to work towards creating a society that is healthy, equal, and fair. We strive to become the best example in the world for implementing “Universal Health Coverage” and “Health for All” advocated by WHO.

The amendment listed 19 Articles on the precautions for cosmetics for children. It advises the manufacturers that, when designing and developing products, the safety and health of children shall be prioritized under normal usage, dosage, and other foreseeable circumstances of using the products. Manufacturers shall preferentially choose ingredients with the history of safe use, while reducing the use of flavors, fragrances, colorants and preservatives. Moreover, in case of children using the cosmetics inappropriately,  manufacturers are suggested attach the text “To maintain children’s safety, please use the product under the supervision of an adult” or other labels with similar meanings, and the other mandatory precautions for particular ingredients,. Revising and updating the regulations will help protect the safety of cosmetics used by children in Taiwan.

TFDA advises that the industry shall give precedence to the safety of children when developing and manufacturing cosmetics for children while referring to the Guidelines and the provisions of the Cosmetic Hygiene and Safety Act. TFDA will keep updating related regulations properly so as to ensure the safety of cosmetics for children.

    In 2022, the following regulations have been announced or amended according to Article 19, Article 33, and Article 52 of the Medical Devices Act, respectively:

1. TFDA announced that starting from June 1, 2022, license holders of Class III medical devices are required to upload UDI and corresponding product information to the UDI Database (UDID).  Medical device manufacturers are also required to place UDI on the product label.  In addition, starting from June 1, 2023, Class II medical devices are required to meet relevant regulations of UDI.

2. Taking technology development into account and making it easier for consumers to obtain instructions, TFDA announced that 38 types of medical devices can have paper instructions replaced with electronic ones since March 8, 2022.

3. To ensure the quality of COVID-19 antigen home/self-test in Taiwan, TFDA amended the Regulations Governing Border Inspection and Examination of Imported Medical Devices.  COVID-19 antigen home/self-test has therefore been subject to the provisions governing medical device items that require border inspection by the central competent authority since July 8, 2022.

1.For the source control, designated products, such as meat products, fishery products, egg products, dairy products, and so on, are required to undergo systematic inspection prior to access of import. Along with routine inspection, the management conditions of product source are audited.
In addition, through the food alert monitoring mechanism, internationally alerted or suspected products are monitored, which is also one of the measures to strengthen source control.

2.For border inspection, information of the product safety from worldwide, scientific evidences, and inconformity records are taken into consideration while implementing either batch-by-batch, reinforced or regular randomly-selected batch inspection. 

3.Once foreign foods declared the border clearance, TFDA also implements post-market inspection and examination, especially on the products of potentially high risks, high concerns, and high occurrence of inconformity, to stop off inadequate products.

According to Act Governing Food Safety and Sanitation, import regulations and measures are officially promulgated and revised along with counseling activities to ensure and safeguard our food safety.

TFDA commits its efforts through the three tiers control measures of food import to safeguard the public health relating to food safety.

    The “Framework of the Cooperation on the Medical Products Regulation” was signed by Taiwan-Japan Relations Association and Japan-Taiwan Exchange Association in November 2013, both sides host Annual Joint Conference in alternative turns for ten years. This year, the representatives from TFDA, MHLW and PMDA share the latest information of medical products regulations, as well as other important topics such as digital tools for clinical trials, measures in response to COVID-19, updates medical devices regulation.

    This year is 10th anniversary for this bilateral conference, we will organize the 10th anniversary session to retrospect the achievements between Taiwan and Japan over the past 10 years. At this major milestone, Taiwan and Japan will continue to promote the communication of legal information, strengthen the cooperation between the bilateral officials and the industries, help the industry to expand the international market, and protect the health and well-being of the public. It also hold a grand event both onsite and online with about 500 people participating.

    We hope that through this meeting, the industry from both sides will have a better understanding of the regulations and create a new blueprint for the collaboration between Taiwan and Japan on medical products regulations.

The conference is held in hybrid mode and invites a lineup of the speakers, including Dr. Jennifer Jimenez, diversion group supervisor of the U.S. Drug Enforcement Administration; Dr. Yih-Ing Hser, professor of University of California; Dr. Jhi-Joung Wang, chair professor of Chi Mei Medical Center; Dr. Chih-Peng Lin, chief of Division of Pain Medicine, National Taiwan University Hospital; Dr. Chin-Cheng Chien, vice superintendent of Cathay General Hospital; and Dr. Wei J. Chen, director of Center of Neuropsychiatry Research, National Health Research Institutes. They will shed light on the abuse of controlled drugs in both the U.S. and Taiwan, related issues from a clinical perspective, management and the preventive measures being taken.

TFDA reviews and revises the relevant norms of the " Controlled Drugs Act" from time to time; TFDA also evaluates and manages drugs emerging internationally or recently. At the same time, TFDA formulates an audit plan for controlled drugs management every year, including the inspection of the rationality of the use of controlled drugs prescriptions to prevent doctors from improperly prescribing controlled drugs that leads to iatrogenic addiction, so as to ensure public medication safety.

About 100 people from the government agencies participate in this event. By serving as a platform where experts can share and discuss experiences, the conference seeks to improve regulations and administration guidelines on controlled drugs and, ultimately, ensure public health and drug safety.

TFDA conducts the medical devices regulatory science CoE training on a yearly basis since 2019, in order to achieve Taiwan’s goal of promoting medical device regulatory convergence, capacity development and international cooperation.  

  In order to raise drug abuse prevention capability of indigenous people, TFDA entrusted Tzu Chi University with the Community Personnel Training Project on Drug Abuse Prevention. Course subjects included drug abuse prevention, how to recognize illegal drug, how to refuse use of drug and community teaching skills, also practical experiences shared. A total of 108 people has been trained in 2021, among them 10 have been invited to hold health education activities within their own tribes with the advantage of same cultural background and interpersonal familiarity, more local people were engaged and 716 indigenous people obtained benefit. Thus, local people have joined together to protect the health of their home villagers.

To prevent the use of camouflaged drug that looked like jello, coffee pact, tea bag and candy out of curiosity, TFDA trained local seed teachers to help indigenous tribe people to recognize new psychoactive substances (NPS) as well as how to refuse using them, to be more alert, and to notice the suspicious signs of drug abuse, thus reduce the risk of exposing to drug. More information on drug abuse prevention and drug harm can be found at TFDA antidrug resources web page (http://www.fda.gov.tw/TC/site.aspx?sid=10070&r= 1203548564).

The TFDA emphasizes that the above-mentioned imported products for personal use exempt from imported inspection may not be sold. Anyone who sells the products shall be deemed in violation of paragraphs 1 and 3 of Article 30 of the Act Governing Food and Safety Sanitation. A fine between NT$30,000 and NT$3,000,000 shall be imposed in accordance with Article 47 of the same act. In addition, application for inspection exemption may be suspended for one year in accordance with paragraph 2 of Article 51.

The TFDA reminds the general public that a balanced diet, regular daily routine, and moderate exercise are the foundation of a healthy life. If supplements or nutritional foods are needed, first consult with a physician, nutritionist, or medical practitioner for an opinion on the foods that best suit individuals’ needs. Before intake, carefully read the recommended intake, warnings, and precautions on the product label. In case of discomfort after product consumption, immediately stop product use and seek medical attention. For healthcare related information, go to the National Health Food and Tablet and Capsules Unexpected Reactions Reporting System.

JFDA editors have been devoted continuingly to enhancing the quality of its articles so it maintains a recognized place in the field of food and drug research. It contains review articles and original articles in the fields of medicine, toxicology, food, medical devices, and cosmetics, focusing on the topics of food, drug, and chemical analysis. Furthermore, to support more convenient services to readers and authors, JFDA official website has been optimized by adding features such as "Selected Picture Marquee", "Top Ten Downloaded Articles" and "Daily Selected Articles". These services make the website livelier and increase more opportunity that the articles be read. Meanwhile, the updated Editorial Manager system with a friendly and convenient interface design allows users to submit or review easily and conveniently.

The latest 2022 issue (number 1 of volume 30), has been published in JFDA official website on March 17^th. Everyone is welcomed to download and read the full text of JFDA for free, or use Editorial Manager system for submission (JFDA official website: https://www.jfda-online.com/journal/; JFDA Editorial Manager system: https://www.editorialmanager.com/jfda/).

As Taiwan’s Medical Device Act and European Medical Device Regulation (MDR) have come into effect in this May, the TCP II was no more valid on 25th May 2021.  In consideration of the TCP II partners could smoothly transfer to TCP III under the COVID-19 pandemic, a transition period of TCP III was taken into force, and will be expired at the end of 2021.

To be more specific, the period of time for applicant to submit supplementary documents following either preliminary or secondary reviews is shortened from two months to one month. The applicant will be allowed to provide the required documents for one time. With regards to the mode of relief, the administrative reconsideration petition can be filed within six months for the dismissed cases after either preliminary or secondary reviews. Furthermore, the on-site inspection may be conducted by central competent authority during the process of reviewing as necessary. To shorten time and promote the efficiency for case reviews, product analysis can synchronously be applied to carry out while the documental reviews is under way.

The Food and Drug Administration of the Ministry of Health and Welfare continues to strengthen the consultation and provide assistance for the health food industry during the application for health food registration including holding several briefing sessions annually, providing consultation services to assist businesses in technical and regulatory issues, which will help case review smoother and more transparent. The information for consultation service can be inquired on the official website of the Food and Drug Administration of the Ministry of Health and Welfare (http://www.fda.gov.tw/ENG/index.aspx; Home > Food > Registration > Health Food).

EUA requests are evaluated based on the scientific evidence such as clinical, pre-clinical, and Chemistry, Manufacturing and Controls (CMC) data. To date, TFDA has issued 3 imported COVID-19 vaccines, AstraZeneca (AZ), Moderna and Pfizer-BioNTech, and a domestically developed vaccine manufactured by Medigen Vaccine Biologics Corp. Medigen vaccine trial results met the EUA standards announced in June 2021 and it is the first protein-based COVID-19 vaccine to be made available in Taiwan.

TFDA announced several digital health related guidelines, including the field of AI/ML, software as medical devices, cybersecurity, and intelligent technology medical devices.  The “Guidance on the qualification and classification of software as medical device” was revised on Dec. 24th, 2020 for better understanding the difference between Medical Software and Medical Device Software.  In addition, due to technology flourishing on the IoT, wireless network and the cloud platform, the “Guidance on Medical Device Cybersecurity Applicable to Manufacturers” was updated on May 3rd, 2021.  Moreover, the “Guideline for Artificial Intelligent / Machine Learning-Based Software as a Medical Device Registration” was announced on Sep. 11th, 2021.  Since there are more and more computer-assisted detection or triage medical device software, the “Technical Guidance on Registration and Market Approval of AI/ML-Based CADe SaMD” was published on July 7th, 2021 accordingly.

Globalization brings industries and competent authorities ever closer together, TFDA is willing to consistently share our experiences and expertise through activities and other ventures from an international perspective.  Through the understanding and learning processes among peers, we can remain up-to-date in the global medical device field and promote products that offer better health.

EUA requests are evaluated based on the scientific evidence such as clinical, pre-clinical, and Chemistry, Manufacturing and Controls (CMC) data. To date, TFDA has issued 3 imported COVID-19 vaccines, AstraZeneca (AZ), Moderna and Pfizer-BioNTech, and a domestically developed vaccine manufactured by Medigen Vaccine Biologics Corp. Medigen vaccine trial results met the EUA standards announced in June 2021 and it is the first protein-based COVID-19 vaccine to be made available in Taiwan.

The COVID-19 vaccines authorized under EUA have undergone and will continue to undergo safety monitoring. TFDA will ensure the quality, safety and efficacy of these products meets regulatory standards..

Since the “Framework of the Cooperation on the Medical Products Regulation” was signed by Taiwan-Japan Relations Association and Japan-Taiwan Exchange Association in November 2013, both sides host Annual Joint Conference in alternative turns for nine years. This year, the representatives from TFDA, MHLW and PMDA share the latest information of medical products regulations, as well as other important topics such as COVID-19 measures, orphan drugs regulation, implementation for new medical devices regulation and emerging topics of medical devices, such as Unique Device Identification (UDI) regulation and Next Generation Sequencing (NGS) topic. Due to the impact of pandemic, this year’s conference is conducted as a webinar. Apart from the TFDA and MHLW and PMDA, around 500 participants from industries join the conference. The deliverables of this conference include reaching and enhancing the mutual understandings of the regulatory information and the collaborations between regulatory authority and industries.

APEC is one of the most important multilateral economic cooperation forums for regulatory authorities in the Asia-Pacific region. TFDA has been participating in the APEC LSIF-RHSC to promote regulatory convergence for a long time. The agency was endorsed as a formal Center of Excellence (CoE) for the training on regulatory science of medical devices on June 15, 2020, and hosted the ‟2020 APEC Medical Devices Regulatory Science Center of Excellence Workshop” from August 28 through September 11 in 2020 that received great acclaim. TFDA is working towards establishing a closer relationship with APEC LSIF-RHSC and conducting the APEC CoE training on a continuous basis, in order to achieve Taiwan’s goal of promoting medical device regulatory convergence, capacity development and international cooperation. 

The rapid rise and abuse of NPS and illegal drugs have long become a global issue. The ongoing pandemic has only made matters worse, leading to rampant criminal activity. This is a public health issue that Taiwan needs to address proactively, as there are various types of NPS and illegal drugs in the market, and their prevalence is increasing every year. The workshop attracts over 200 participants from industry, government, and academia. Their exchange of insights will be instrumental as Taiwan seeks to improve its analytical capabilities and, ultimately, safeguard citizen’s health and drug use.

Due to the COVID-19 pandemic, the workshop is conducted virtually this year, where scholars and experts from France, Belgium, Australia, Thailand, Vietnam, Malaysia, the Philippines, Japan, and Taiwan gather to discuss detection technologies and future challenges regarding NPS and illegal drugs with the local health bureau, investigation bureau, police, procurator and customs. Their contributions will help Taiwan keep its analytical capabilities up to date with international standards and facilitate a platform for exchanges and collaboration. With joint efforts from all circles, we are all better equipped to stem the spread of NPS and illegal drugs.

AHWP/GHWP is a voluntary group of regulators and industry members with the goals of developing and recommending approaches for the convergence and harmonization of medical device regulations in Asia and other regions. Taiwan has been an official member since it was established in 1999. TFDA was elected as the Chair of In Vitro Diagnostic (IVD) work group (known as WG2) in 2012, and has continued in office for other terms until now.

Being the most active work group in the AHWP/GHWP Technical Committee, WG2 has been focusing on the promotion of global harmonization in the premarket review processes, and assisting AHWP/GHWP member economies in implementing regulatory framework of IVD medical devices. In the period of Taiwan chairing the WG2, it has already developed fourteen guidance or reference documents and endorsed by the AHWP/GHWP. Furthermore, Taiwan has been active in leading WG2 to collaborate with other AHWP/GHWP work groups and international organizations. Due to the COVID-19 pandemic, WG2 has been assigned as the Joint Working Group (JWG) leader for developing the guidance related to the emergency regulatory mechanisms for medical devices. Furthermore, as WG2 Chair, TFDA routinely joins the International Medical Device Regulators Forum (IMDRF) IVD working group meetings for reviewing and updating the Principles of IVD Medical Devices Classification document. The updated guidance taking into account the current level of development and experience in applying the risk-based approach to the classification of IVD medical devices, has been published on the IMDRF official website on May 21, 2021. In addition, WG2 has established a long-term cooperation relationship with WHO IVD pre-qualification team to contribute technical comments to WHO Technical Specification and Technical Guidance documents.

The continuous and significant participation of TFDA in global medical device regulatory organizations, sharing knowledge and expertise with the global regulatory professionals, have been greatly showing Taiwan’s medical device regulatory leadership and significant role in Asia and beyond.

To reduce the occurrence of foodborne disease, first of all, it’s necessary to practice proper hands hygiene before eating or preparing food. Foods should be stored in the refrigerator as soon as possible and do not be left at room temperature for too long. Furthermore, raw food should be kept separately from the cooked food to prevent cross contamination. As to the seafood, they should be heated thoroughly prior to consumption. In addition, wild plants and animals should be avoided, because some of them may be poisonous to humans.

TFDA promotes “Five keys and two don’t principles to prevent foodborne disease” as follows:

1. Wash hands: wash hands with soap, and rinse by clean water before handling food, during food preparation and before meals.

2. Keep fresh: ensure the cleanness of water used, and select and keep freshness of foods.

3. Separate raw and cooked: use separate equipment and utensils for handling raw materials and prepared foods to prevent cross contamination.

4. Cook thoroughly: prepare and cook foods thoroughly, at least to 70°C of the center temperature.

5. Preserve at proper temperature: keep foods at low temperature (no higher than 7℃) or preserve them in adequate means, and do not leave food at room temperature for too long.

6. Don’t drink untreated water: water should be brought to a rolling boil for one minute to kill pathogens.

7. Don’t eat wild plants and animals: avoid consuming wild plants and animals, because some of them may be poisonous to humans.

The inspection shall follow the Regulations on Good Hygiene Practice for Food (GHP) and Hazard Analysis and Critical Control Points (HACCP). In addition, the processed eggs and raw eggs will be sampled to run tests on content such as heavy metal, preservatives, Sudan stain, microbiological analysis or veterinary drug residues.

TFDA urges food businesses to supervise themselves more by following the “Act Governing Food Safety and Sanitation”. Any violation of GHP found and not corrected within the designated time limit or any incompliance of products with the regulations will be subject to fines to protect the food safety of the consumers.

守護飲食用藥安全 引領科技全新紀元 創造安心消費環境

消費者保護專線：1919(全國食安專線)、02-27878200 網址：http://www.fda.gov.tw

N-Butylpentylone and N-Butylhexedrone are synthetic cathinones；Methyl-3-oxo-2-phenylbutyrate can be refined into P2P (precursor ingredient for making amphetamine and methamphetamine), while fluorophenylacetone and methoxyphenylacetone can be refined into amphetamine type narcotics like fluoroamphetamine and methoxymethamphetamine. Cathinones and amphetamines are central nervous system stimulants that are highly addictive, and may produce toxicological reactions such as tachycardia, hypertension, hyperpyrexia, hallucination and paranoia.

The Taiwan Food and Drug Administration(TFDA) would like to remind institutions and companies keeping such controlled drugs to apply for controlled drugs registration license as per regulations, and to maintain records of daily increase and decrease of stocks, destruction, loss and inventory of controlled drugs at their business department and report them periodically. Institutions and companies wishing to use the aforementioned substances for medical or educational research must submit an application for use of controlled drugs to the MOHW. To avoid penalties, the application must be approved before the controlled drugs can be used.

Following world trends, Taiwan has amended the Pharmaceutical Affairs Act and stipulated a new law specifically for the management of medical devices. With the Medical Devices Act in place, Taiwan could establish an appropriate management system that takes the characteristics of medical devices into consideration. The new Act covers repair and maintenance of medical devices, sale and supply of medical devices, quality management system and distribution management of medical devices, electronic listing system for some low-risk products, flexible validity period for issuing licenses, medical device clinical trials, safety monitoring of medical devices, proactive reporting and more, to protect consumer safety and improve management of medical devices.

According to Taiwan Food and Drug Administration (TFDA), at present, TFDA has completed the drafting of relevant regulations and regulatory orders related to the Medical Devices Act, including Regulations Governing the Classification of Medical Devices, Regulations Governing Issuance of Medical Device License, Listing, and Annual Declaration, Regulations of Medical Device Tracking Management, and Regulations for Management of Medical Devices Technicians. The government has also introduced various measures to give medical device firms reasonable transition period to make adjustments and to minimize the impact to the industry.

Director-General Shou-Mei Wu of TFDA states that Taiwan's medical device management system will continue to follow international trends. Taiwan will work to harmonize with international regulations and reduce regulatory barriers that Taiwanese medical device dealers face when they attempt to compete in the international market. At the same time, Taiwan will also work to protect consumers' safety when they use medical devices, promote the development of the medical device industry, and enhance the competitiveness of medical device businesses in the international arena.

Taiwan Food and Drug Administration (Taiwan FDA) has stated that from July 1, 2021, general toothpaste and mouthwash products will be included in the management for cosmetics, and hence, the labeling, ingredients, quality, hygiene and safety, and manufacturing facilities of these products shall comply with regulations for cosmetics. It is expected to enhance the quality, hygiene and safety of general toothpaste and mouthwash products. General cosmetics shall be notified at the “Cosmetic Products Notification Platform System” established by Taiwan FDA prior to their supply, sale, giveaway, public display, or consumer trial offer of cosmetics. It would be helpful for the competent authority to monitor the items and obtain related information on cosmetics available in the domestic market. New regulations for cosmetics labeling provide clear rules for the items of cosmetics labeling, standardization for the display order of ingredients, and the font sizes of items required to be labeled, which could help consumers to identify directly and check the product information and further improve consumer rights.

In addition, to prompt people from all walks of life understand our regulations, Taiwan FDA has released a video titled “The Current and Future Cosmetics Regulations and PIF” on the website named “Medical Device and Cosmetic e-Learning system”. Please visit this website at http://mdcel.fda.gov.tw/info/10000252 for more information.

The inspection items will focus on the registration requirements for food businesses, the Regulation on Good Hygiene Practice for Food (GHP), the product liability insurance, the self-management, the product traceability, the transport control, the food practitioner sanitation management. And the ice cube products will be checked of labeling and hygiene compliance. Violating provisions of the Act Governing Food Safety and Sanitation will be punished by law.

TFDA strongly recommends food businesses effectively implementing the self-management following the Act Governing Food Safety and Sanitation to ensure ice cubes safety and sanitation to protect the health of consumers.

As stipulated in the regulations, packaged products that contain pork and other edible parts of pig shall clearly indicate their Country (place) of origin in Chinese, whereas, food served in catering place and the bulk food labeling as provisioned by these Regulations shall be labelled in Chinese and in the form of cards, mark (label) or notice boards which in turn are either posted, hung, erected (inserted), stuck or utilized in other ways which are clearly visible.

According to the Act Governing Food Safety and Sanitation, food business operators fail to do the labeling as required shall be fined between NT$30,000 and NT$3,000,000, furthermore, the false labeling shall be fined between NT$40,000 and NT$4,000,000.

 In accordance with Article 2 of Paragraph 8 of the Act Governing Food Safety and Sanitation, food industries falling into the designated categories as manufacturing and processing products with potential risk, such as aquatic products processing industry, meat processing industry, and dairy processing industry, shall comply with the Regulations on Food Safety Control System. On May 1, 2018, the same regulations also applied to other food commodities containing edible fat, canned food and egg products. Industries and products mentioned as above shall meet the regulations on HACCP in stages based on types of products and scale designated.

There are three key points for food industries when carry out the regulations of HACCP:

First, confirm the product processing flowchart consistent with the workplace.

Second, create documents, keep records and retain them.

Third, doing and speaking shall be consistent with writing at all times.

Let’s work together to protect the food safety and sanitation in Taiwan！

ICCR is a voluntary international group of cosmetics regulatory authorities from Brazil, Canada, the European Union, Japan, and the United States established in 2007. This multilateral communication framework engages in regulator coherence of international cosmetic administration regulations to reducing the technical barriers to trade in international cosmetics administration regulations and has been committed to protecting global consumer safety. TFDA has actively participated in ICCR meetings as an observer since 2016, conducting exchanges and discussions on various topics regarding the cosmetics safety, regulations, and public communication between each other. Becoming the Member of ICCR will be a significant outcome for Taiwan’s cosmetic administration regulations towards internationalization.

Due to the frequent update of international cosmetic regulations in recent years, Taiwan also amended various administration according to the international trends, in the implementation of the Cosmetic Hygiene and Safety Act in 2019.

In the future, TFDA will continue to participate in ICCR related events with enthusiasm and to intensify the communication and collaboration with cosmetic competent authorities and industry representatives. Moreover, TFDA will follow the latest international cosmetic administrations and development trends to improve the cosmetic administration regulation in Taiwan and provide assistance for industries with the implementation of relevant regulations. Subsequently, TFDA will protect consumer safety while consider industry development.

     As the COVID-19 pandemic continues to affect the entire world, the demand for medical masks as well as the production capacity continues to increase. To enhance border inspection of imported medical masks, Taiwan Food and Drug Administration amended Regulations for the Inspection and Examination of Imported Medicaments, so that medical masks are included in border inspection. In addition to license of medical devices, imported medical masks are also obliged to meet examination standards, which are divided into different categories, including “general medical masks”, “surgical masks”, "surgical D2 masks" with corresponding inspection items, such as bacteria filtration efficiency, differential pressure, sub-micron filtration efficiency, and respiratory air impedance. On the principles of risk management, imported products will go through batch-by-batch or random-selected batch inspection and only those passing the inspections will be cleared to enter Taiwan. Those failing to pass the inspection will be returned, so our citizens can rest assured that medical masks used meet our standards for quality and performance.

     In addition, for the general public to conveniently recognize domestically manufactured medical masks, from September 24th, 2020 on, all flat medical masks made in Taiwan (including general medical masks and surgical masks) shall bear two debossed stamps "Made In Taiwan"and "MD",which stand for "medical device ". The two stamps will be marked within 1.5 cm distance to the edge of each mask, so flat medical masks will not be mixed with general masks. This announcement will not affect Medical N95 or equivalent respirator masks, nor 3-dimensional masks or medical masks for export only.

      At the beginning of the pandemic, Taiwan has been firing up its new mask production lines to meet the surging demand of medical masks. The government requisitioned masks and used a medical mask rationing system to ensure that every citizen have access to medical masks. In addition, with increasing public awareness of the importance of public health, people in Taiwan are willing to work with the Central Epidemic Command Center and develop the habit of washing hands and wearing masks. These habits allow Taiwan to maintain daily routine during the pandemic. Taiwan's experience can be used as a reference for other countries and we can contribute to get through the crisis.

Director of U.S. Department of Health and Human Services (HHS) for Global Affairs Garrett Grigsby praised Taiwan’s leadership to combat cancer and active contribution to the global health system. He also emphasized that Taiwan should not be excluded from the World Health Organization (WHO) especially during COVID-19 pandemic. Dr. Shih-Chung Chen (陳時中), Minister of Health and Welfare, addressed that many countries believe that they can establish cancer registry systems only after universal health insurance is available. Yet Taiwan’s cancer registry began as a hospital-based system in 1970, then a nationwide population-based system was launched in 1979. These initiatives show that Asia’s first cancer registry preceded Taiwan’s National Health Insurance program, which has provided universal coverage since 1995. Moreover, the completeness of case ascertainment (98%) and data quality of Taiwan’s cancer registry database meets at a gold standard by North American Association of Central Cancer Registries (NAACCR) gold standard registry certification.

Minister Chen also stated that in cooperation with the Ministry of Science and Technology and the Ministry of Economic Affairs, MOHW will launch a platform for healthcare big data and sustainability in 2021 in order to develop a precision health blueprint for the public health in Taiwan. Cancer registry is certainly one of the most important components in this platform. As the Taiwan government is currently implementing the National Cancer Registry Plan 2.0, this platform aims to promote cancer prevention and control by enhancing the application of artificial intelligence (AI) in cancer registry.

The forum was moderated by Dr. Kung-Yee Liang (梁賡義), President of the National Health Research Institutes. Dr. Chien-Jen Chen (陳建仁), Taiwan’s former Vice President, first delivered his speech Nationwide Cancer Registration System in Taiwan: 40-year Achievements and New Challenges, explaining how to adopt big data, machine learning and AI in natural language processing for addressing challenges and innovations in cancer registry. Followed by Dr. Donald Maxwell Parkin, visiting Senior Research Fellow at the Nuffield Department of Population Health, University of Oxford and Head of Cancer Registry Programme of the International Network for Cancer Treatment and Research (INCTR), he underlined the development of cancer registries worldwide and the role of the Global Initiative for Cancer Registry Development (GICR), as well as the importance of building population-based cancer registry data for reducing premature mortality from non-communicable diseases. And lastly by Dr. Serban Negoita, famous American cancer registry scholar, shared American Surveillance, Epidemiology, and End Results (SEER) Program, linking data from multiple sources representing each patient’s trajectory over their disease course to evaluate the treatment outcomes. Moreover, Dr. Gijs Geleijnse, Data Science Team Lead and Innovation Program Manager at the Netherlands Comprehensive Cancer Organization (IKNL), shared that the Netherlands has collaborated with Taiwan on federated learning in recent years, using AI in an innovative approach to compare and analyze cancer registry data of the two countries without sending those data abroad. Also present at the forum were Ambassador-at-Large Yung-Tung Wu (吳運東); Secretary General Yung-Min Chang (張雍敏), Counselor Li-Ling Liu (劉麗玲) of Ministry of Health and Welfare; Director-General Ying-Wei Wang (王英偉) of Health Promotion Administration; Secretary General Li-Wen Hsu (徐儷文) and Director-General Loong-Jin Chen (陳龍錦) of the Ministry of Foreign Affairs.

In the closing remarks by Director of American Institute in Taiwan Brent Christensen, he stressed that Taiwan and the U.S. have wide ranging partnership on health for over 20 years. Moreover, this partnership was further solidified with the signing of an MOU on health cooperation during the August visit to Taiwan by the U.S. HHS Secretary Alex Azar II. The U.S. looks forward to seeing Taiwan play a bigger role in the cancer research effort in the years to come. Minister Shih-Chung Chen concluded that Taiwan, as a global citizen, is willing to share its experience in integrating AI into national cancer registry, showing not only that “Taiwan can help” but that “Taiwan is helping” with concrete actions as well as making contributions to Taiwan’s bid to participate in the WHO.

October 30, 2020

Using genetic modified mouse models, research at the National Health Research Institutes (NHRI) has shown promise for advances in understanding the causal relationship between muscle aging, thermogenesis, and mortality.

Lamin A is a component of the nucleoskeleton. De novo mutation of human lamin A gene (i.e. LMNA) generated progerin protein, which is causal to the Hutchinson-Gilford progeria syndrome (HGPS). The aging process in HGPS patients is about 8 time faster than normal people. Dr. Chi and her team developed a mouse model which conditionally overexpressed with human progerin in muscle, and discovered that muscle‐specific overexpression of progerin was sufficient to induce muscular dystrophy and alter whole‐body energy expenditure, leading to premature death.

 The team found sarcolipin (Sln), an ER‐associated protein involved in heat production, is upregulated in the skeletal muscle expressing progerin. The depletion of Sln accelerated the early death of Lmna mutant mice. A further examination at the molecular level revealed that progerin recruits Sln and Calnexin to the nuclear periphery. Furthermore, progerin‐expressing myoblasts presented enhanced store‐operated Ca²⁺ entry. These findings suggested that progerin dysregulated calcium homeostasis through an interaction with a subset of ER‐associated proteins, resulting in thermogenic and metabolic abnormalities.

This research was recently published in Aging Cell. For the full text of the publication, see:

1. Wang, W. P., Wang, J. Y., Lin, W. H., Kao, C. H., Hung, M. C., Teng, Y. C., Tsai, T. F. and Chi, Y. H. (2020) Progerin in muscle leads to thermogenic and metabolic defects via impaired calcium homeostasis. Aging Cell Feb;19(2):e13090.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6996945/

With a view to strengthening the management of medicinal products distribution, Taiwan Food and Drug Administration (TFDA) stipulated the “Regulations governing the trace and track system for medicinal products” based on Pharmaceutical Affairs Act on September 6, 2016.TFDA has given priority to include specific medicinal products in the trace and track system of medicinal products since July 1^st, 2017. Currently TFDA has included blood preparations, vaccines, Botox, high concern type 50 items, preparations of ephedrine/pseudoephedrine and medicinal nitrous oxide in the system.

There are diverse ways for the pharmaceutical company to declare the trace and track data, such as data import, automatic upload, or online data entry etc., and the operating interface of the declaration system was improved to simplify the declaration process for pharmaceutical company. In addition, the system has established the cross-reference and statistical analysis function, which is able to provide statistics, inquiries, and output of reports. Furthermore, the authority is given to the medicinal products license holders for conducting query and cross reference of declaration information in the national health insurance database, assisting in the flow control of prescription medicinal products, and enhancing the management of medicinal products flow for the pharmaceutical firms.

Since the “Framework of the Cooperation on the Medical Products Regulation” was signed by Taiwan-Japan Relations Association and Japan-Taiwan Exchange Association in November 2013, Taiwan Food and Drug Administration (TFDA) works with Japan’s Ministry of Health, Labour, and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) to host Annual Joint Conference in alternative turns for eight years. This year, the representatives from TFDA and MHLW and PMDA share the latest information regarding the pharmaceutical regulations, as well as other important topics such as regulatory challenge against COVID-19, recent regulatory challenge in medical devices and Quality Management System (QMS) utilization of MOC. Apart from the TFDA and MHLW and PMDA, around 200 participants from both Taiwan and Japan’s industries join the conference. The deliverables of this conference include reaching and enhancing the mutual understandings of the regulatory information and the collaborations between regulatory authority and industries.

The definition of a biosimilar product is “a biological product that is highly similar to and has no clinically meaningful differences from an existing regulatory authority approved reference product.”  Biological products are produced through biotechnology in living systems. Due to the complex nature of the living systems and manufacturing processes, slight differences are expected between reference products and biosimilar products. Despite the slight differences, biosimilar products behave no clinically meaningful differences from the reference products. Therefore, a biosimilar product can only receive market approval if it demonstrates and proves that its quality, safety, and efficacy (active ingredients, structure and function) are highly similar to the reference product through comprehensive comparative analyses and testing, which include drug structure analyses, functional analyses, identifications, non-clinical studies and comparative clinical studies, etc.

To ensure the safety, purity, and potency (safety and effectiveness), of the biosimilar products have no clinically meaningful differences from the reference products, TFDA has announced several guidance for biosimilar products since 2010 and has established thorough and rigorous review processes. To date, TFDA has been approved 17 biosimilar products in Taiwan, which are growth hormone, insulin, anti-immune rheumatism and anti-cancer drugs.

Biosimilar products enable patients to access innovative medicines and provide more affordable options, without compromising on the efficacy or safety. In order to provide safe and effective biosimilar products, TFDA is committed to continuously improving its review and management system. Moreover, to help the public to understand more about biosimilar products, TFDA has established a biosimilar drug section on the TFDA official website. For more information on biosimilar products, please refer to http://www.fda.gov.tw/TC/siteContent.aspx?sid=11262 .

The abuse of NPS continues to be reported, and in recent years, drug dealers attempt to evade inspections and crackdowns, and create more NPS by slightly modifying the chemical structures of existing illegal drugs, which promotes the difficulty for management and screening testing. Besides, there are increasing incidents about illegal food and drugs reported in recent years, such as food and drug adulteration, counterfeit Crestor tablets, and faked Viagra containing analgesic ingredients. The yearly-increasing illegal events become the important public issue, which have already caused health threats and social problems, to be solved.       

TFDA is in cooperation with a number of health agencies, the Customs Administration, and law enforcement, and applies the advanced analytical technologies to prevent the spread of NPS and illegal drugs. The workshop will serve as a platform for participants to exchange views and share the experiences in advanced technologies related to NPS and illicit drugs, which would strengthen domestic analytical ability, and ultimately protect the public health and drug safety.

1. Online application:

    Since 2016, TFDA has gradually promoted the online application for the sanitary certificates, manufactured sanitary certificates, test reports and certificates of free sales and manufacture. A total of more than 6,000 online application cases has been accepted. Food businesses operators no longer need paper delivery, and online supplements have been more efficient.

2. Simplify the application documents:

    To improve the online application measures, TFDA completed the cross-system information connection between the "Food and Drug Operator Registration Platform" (FadenBook system) and the “Application System for Export Food Sanitary Certificates” (Asefsc system) in 2019, including the basic information of the food businesses operators, the registration of the manufacturing plant, food additives registration information, food additives permits, etc. TFDA also integrate multiple manufacturers' statement declaration documents, instead of being checked online, to achieve the goal of simplifying application documents.

3. Simplify the application process:

    Since October 1, 2017, the manufacturer has the valid certificate of the second-tier quality control verification, and since April 15, 2019, the manufacturer has been audited by the competent authority and compliant with the GHP, those who meet the stipulated conditions could be issued sanitary certificates after passing the paper review, eliminating the need to conduct the on-site verification process again. The speed of application can be up to 4 times faster.

4. Electronic notification:

    Since October 1, 2019, the system started to notify by e-mail to the FBO for payment and receiving certificates. It’s save time on delivery and get more real-time information.

5. Multiple payment methods:

    Since October 1, 2019, 7 diversified payment channels have been provided. Operators can freely choose a suitable payment method, increasing the convenience of payment.

    The food business operators who have application requirements can use TFDA's " Application System for Export Food Sanitary Certificates (Website: http://asefsc.fda.gov.tw)" to inquire about relevant application information.

    Those who imported and sold foods and related products into Taiwan without permission shall be fined between NT$30,000 to NT$3,000,000 because of the violation of the Act.

APEC is one of the most important multilateral economic cooperation forums for regulatory authorities in the Asia-Pacific region. TFDA has been participating in the APEC LSIF-RHSC to promote regulatory convergence for a long time, and has hosted the ‟2019 APEC Medical Devices Regulatory Science Center of Excellence Pilot Workshop” from October 22 through 24 in 2019 that received great acclaim. In this year, TFDA was endorsed in June to become a formal Center of Excellence (CoE) for the training on regulatory science of medical devices. With this endorsement, TFDA is working towards establishing a closer relationship with APEC LSIF-RHSC and conducting the APEC CoE training on a continuous basis, in order to achieve Taiwan’s goal of promoting medical device regulatory convergence, capacity development and international cooperation.

Taiwan and the United States have more than 20 years of public health cooperation, addressing topics such as emerging infectious diseases response and dengue vaccine research. First executed by the Taiwan Ministry of Health and Welfare and the United States Department of Health and Human Services, this MOU further expands the cooperation in areas including global health security, infectious disease prevention and control, chronic disease prevention and health promotion, maternal, infant and adolescent health, environmental health, occupational health, tobacco control, health inequality, digital health, misuse of opioids, health communication and human resources for health. Other areas of potential cooperation may also be included in the future after discussion. Under the framework of the MOU, cooperation activities are conducted by cooperative programs, science and research projects, personnel exchange, training and bilateral visits, consultations, meetings, workshops, and conferences, as well as establishment of contact points to facilitate exchange of best practices, expertise, and information. This MOU aims to enhance the health and wellbeing of people of Taiwan and the United States as well as promote global health security together.

The items of inspection will not only focus on the Regulations of Good Hygiene Practice (GHP) compliance, especially the legality of raw materials, products’ labeling but also examine the legitimacy of food additives such as preservatives and bleaching agents via sampling the processed products. Food businesses could be fined if any non-conformances of GHP are not validated in time or any final products not in compliance with the regulations.

          The focus of the inspection includes food industry login, the      implementation of Good Hygiene Practice for Food (GHP), product   liability insurance, warehouse management and the product               traceability and management of raw materials. Foods that are not     baked at high temperatures, ready-to-eat baked goods which include "lettuce" and "salad," and cakes and breads with fillings sold at       room temperature will be inspected. Any food manufacturer who      violates the “Act Governing Food Safety and Sanitation” is liable to  punishment according to the relevant regulations and laws handled  by the local health bureau to uphold the food safety of the general     public.

    During the meeting, TFDA will present “Taiwan’s Model” for containing the COVID-19 outbreak, in particular the expedited review process, emergency use authorization (EUA), the measures of proactive stock monitoring and prevention of uneven distribution of drugs and medical devices, as well as the experience of production maximization, tariff reduction and exportation control of alcohol-based sanitizers. All participants from the globe will also be invited to share their measures and experience against the COVID-19 pandemic. TFDA looks forward to establishing enhanced collaboration and concrete friendship with international partners through this meeting and together to combat against COVID-19.

    Given that the efficacy and safety of Remdesivir supported by preliminary evidence, the drug has been approved by other health authorities internationally. Taking into account of domestic public health needs and the medical benefit as well as the risk assessments, the participating experts suggested TFDA consider conditional approval of Remdesivir for patients with severe SARS-CoV-2 infection, according to the Article 48-2 of Pharmaceutical Affairs Act, provided that the pharmaceutical company would implement a risk management plan (RMP) to ensure the safety after the importation.

TFDA spares no effort in promoting anti-drug task and actively implements “New-generation Anti-drug Strategy.” TFDA also strengthen border control on active pharmaceutical ingredients (APIs), integrate testing resources, and enhance the inspection capabilities of government and private testing institutions. All the actions aim to keep illicit drugs outside of the border and protect people’s health in Taiwan.

Recently, newly emerging drugs are disguised in various forms, such as jelly, coffee bags, tea bags, plum cakes, and candies, to escape police seizures. These kinds of drugs also attract people's attention and curiosity, let down their guard as well as induce them to use. TFDA appeals to the public to keep alert to drugs at all times and watch out for their safety. People should turn down drugs, drinks, or food of unknown origin, and never try for the sake of curiosity or instigation.

      For more information on drug abuse and harm, please visit TFDA’s website (http://www.fda.gov.tw/TC/site.aspx?sid=10070). The toll-free counseling hotline of County and City Drug Abuse Prevention Centers at 0800-770-885 is also available.

Taiwan deeply regrets that the World Health Organization continues to deny Taiwan's Observer status at the World Health Assembly for political reasons.

While Taiwan was not invited to take part in the WHA this year, it deeply appreciates the efforts made by the United States, Taiwan's diplomatic allies, and other like-minded countries in support of its case. In more than 20 years of robust cooperation on public health and biomedical research, Taiwan and the US have addressed such wide-ranging topics as the response to the SARS outbreak, regional training for Zika diagnostic tools, burn treatment, cancer research, and dengue vaccine research. Now this cooperation has expanded to include the coronavirus disease 2019 (COVID-19) pandemic by sharing a number of measures and strategies Taiwan has implemented to contain the outbreak.

As the entire world works together to fight COVID-19, Taiwan's successful experience can serve as a model for the global community. By continuing to exclude Taiwan, a willing and responsible partner and stakeholder, WHO has failed in its pledge to leave no one behind and created a gap in the global health network.

Indeed, as COVID-19 stalks the globe, more and more countries are realizing that Taiwan's exclusion from WHO poses a dangerous risk to global health and safety, and that Taiwan's participation would be a positive contribution to WHO. This is illustrated by the widespread international support that Taiwan has received in its bid to play a professional, pragmatic, and constructive role in WHO.

As the most important international organization overseeing the development of global public health and the defense of the right to health, WHO should maintain a position of professionalism and neutrality. Taiwan urges WHO to ensure independence from political pressure, abide by its own call to work for the highest attainable standard of human health, and fully include Taiwan in its meetings, mechanisms, and activities, including the WHA.

Taiwan is grateful for the staunch, longstanding support from the United States, Taiwan's diplomatic allies, and other like-minded countries for ensuring Taiwan's meaningful participation in WHO meetings so that Taiwan can make further global contributions. Taiwan will continue to work with these countries and observe the principles of professionalism, pragmatism, and making contributions as it seeks to broaden its international participation.

     Minister of Health and Welfare Chen Shih-Chung (陳時中) addressed that in response to the COVID-19 outbreak, Taiwan has set strategies for epidemic surveillance, border controls, community-based prevention and control, stockpile of medical supplies, and health education and outreach, which have adopted measures including expanding community-based monitoring, strengthening laboratory diagnostic capacity, banning foreign nationals transiting or entering Taiwan, requiring inbound travelers to undergo a 14-day home quarantine, connecting community quarantine through the smart quarantine system, establishing a name-based rationing system for face masks distribution, and implementing social distancing, to prevent the spread of the disease and keep health and safety of the people in Taiwan. In addition, Minister Chen revealed that Taiwan’s successful response to COVID-19 lies in six key aspects: rapid mobilization between the government and the private sector, prompt decision-making, thorough implementation of measures, well-coordinated distribution of medical supplies, transparent information and advanced technology so that the people in Taiwan can maintain normal life and daily activities with only a few cases of local transmission occurred.

     In the forum, Digital Minister Audrey Tang (唐鳳) of Taiwan Executive Yuan shared Taiwan’s experience in combating COVID-19 using digital technology. Director-General Chou Jih-Haw (周志浩) of Taiwan Centers for Disease Control reviewed the COVID-19 prevention and control strategies and discussed prevention and control measures, evacuation flights, and risk communication in response to the COVID-19 epidemic, while underlining the importance and necessity of Taiwan's inclusion in the WHO for combating COVID-19. Also present at the forum were Ambassador-at-Large Yung-Tung Wu (吳運東), Deputy Minister Chi-Kung Ho (何啟功), Secretary General Shun-Ping Cheng (鄭舜平), Counsellor Li-Ling Liu (劉麗玲) of Ministry of Health and Welfare and Director-General Bob L.J. Chen (陳龍錦) of the Ministry of Foreign Affairs.

     As the COVID-19 pandemic spread rapidly across the globe, Taiwan will continue to offer humanitarian aid through bilateral and multilateral channels, as well as share our experience and expertise, to show that Taiwan can help and Taiwan is helping!

TFDA would like to remind all consumers to choose trustworthy sellers and be cautious regarding information provided by the seller. The TFDA has suggested the following four principles of online grocery shopping：First, pay attention to the information, quantity, net weight, and food business registration number of the product；Second, make sure to scan the QR code provided by the seller if detailed information cannot be found on the website；Third, pay attention to the category and price of the product and make sure that the date and method of delivery are reasonable before you place your order；Finally, check to see if the packaging is damaged or if any foods are missing or rotten upon receiving the product. Notify the seller immediately if you come across any issues.

The public may be easily affected by the rumors concerning food products. Therefore, the TFDA has established the Rumor Buster at http://www.fda.gov.tw > News and Announcements > Rumor Buster area to clarify rumors with scientific evidence and provide accurate information to answer public concerns. The TFDA has also established the food and drug consumption area at http://consumer.fda.gov.tw/ to safeguard the food safety of the general public by providing detailed information about food products, food sanitation, and nutritional information. We encourage the public to make good use of our resources to search for true, accurate, and complete information. The public shall also use the four principles of online grocery shopping to purchase and enjoy delicacies with confidence.

      During the meeting, Secretary Azar praised Taiwan on its COVID-19 containment and thanked Taiwan for providing masks. Both sides exchanged COVID-19 prevention strategies as well as shared their views regarding global health security and other key health issues, particularly the need for Taiwan's inclusion in the World Health Organization (WHO).

      Minister Chen expressed his appreciation to Secretary Azar for the recent cooperation between the United States and Taiwan on the efforts to combat COVID-19, also for the strong support extended by the United States for Taiwan's participation in the WHO. Minister Chen told Secretary Azar that he hopes the U.S. will continue to support for Taiwan's full participation in the World Health Assembly as observer and WHO meetings, mechanisms, and activities.

      Secretary Azar reaffirms the continued and concrete support from the U.S. of expanding Taiwan's participation in the WHO and global health arena, which will allow Taiwan to share its health expertise with the world and make greater contributions.

      Before concluding the meeting, both sides agreed to enhance bilateral exchange and to expand health cooperation, especially in research and development of COVID-19 vaccines and medicines, as well as medical supplies and equipment. Both sides looked forward to meeting each other again.

      The meeting between Minister Chen and Secretary Azar lasted over 30 minutes, during which time Minister Chen was accompanied by Director Brent Christensen of AIT, Szu-Chien Hsu(徐斯儉), Deputy Minister of Foreign Affairs, Director-General Chin-Hsiang Yao (姚金祥) and Director-General Bob L.J. Chen Chen (陳龍錦) of the Ministry of Foreign Affairs, Director-General Jih-Haw Chou (周志浩) of Centers for Disease Control, Counsellor Li-Ling Liu (劉麗玲) of Ministry of Health and Welfare.

1. The Taiwan Centers for Disease Control (Taiwan CDC) learned from online sources that there had been at least seven cases of atypical pneumonia in Wuhan, China. In China, the term "atypical pneumonia" is commonly used to refer to SARS, a disease transmitted between humans caused by coronavirus.
2. Owing to its experience with the SARS epidemic in 2003, Taiwan vigilantly kept track of information about the new outbreak. On December 31, 2019, Taiwan sent an email to the International Health Regulations (IHR) focal point under the World Health Organization (WHO), informing WHO of its understanding of the disease and also requesting further information from WHO. Given the lack of clarity at the time, as well as the many rumors that were circulating, Taiwan's aim was to ensure that all relevant parties remained alert, especially since the outbreak occurred just before the Lunar New Year holiday, which typically sees tremendous amounts of travel. To be prudent, in the email we took pains to refer to atypical pneumonia, and specifically noted that patients had been isolated for treatment. Public health professionals could discern from this wording that there was a real possibility of human-to-human transmission of the disease. However, because at the time there were as yet no cases of the disease in Taiwan, we could not state directly and conclusively that there had been human-to-human transmission.
3. The Taiwan CDC also contacted the Chinese Center for Disease Control and Prevention in a bid to obtain more information. However, in response to our inquiries, the WHO IHR focal point only responded with a short message stating that Taiwan's information had been forwarded to expert colleagues; China provided only a press release.
4. Even though Taiwan strongly suspected that human-to-human transmission of the disease was already occurring at the time, we were unable to gain confirmation through existing channels. Therefore, on the day the aforementioned email was sent to WHO, the Taiwan government activated enhanced border control and quarantine measures based on the assumption that human-to-human transmission was in fact occurring. These measures included screening passengers on flights from Wuhan prior to disembarkation.
5. In mid-January, the Taiwan CDC dispatched experts to Wuhan to gain a better understanding of the epidemic, the control measures taken there, and patients' exposure history. Based on preliminary research, Taiwan determined that this form of pneumonia could indeed spread via human-to-human transmission.

      Starting in 1993, JFDA editors have been devoted to enhancing the quality of its articles so it maintains a recognized place in the field of food and drug research. It contains review articles and original articles in the fields of medicine, toxicology, food, medical devices, and cosmetics, focusing on the topics of food analysis, drug analysis, and chemical analysis. Articles on food health effects, analysis and evaluation of food microbes, pharmacokinetics, and Chinese herbal medicines are also featured in this journal. In addition, special issues are published with different themes every year. One of them is the "Benefits or Risks: The Interactions of Drugs with Herbs, Foods, Dietary Supplements and Adjuvants" in 2018, with the theme of the interaction between drugs and Chinese herbal medicine, food and nutritional supplement. Another is the "Special Issue of Mass Spectrometry for Clinical Diagnosis" published in 2019, which mainly introduces preclinical and clinical research through the use of modern mass spectrometry detection technology, and its recent advances in the field of medical research.

      With its diverse content, JFDA authors are from 58 countries, including the United States, China, the United Kingdom, Australia, Poland, Italy, Spain, South Korea, Japan, Malaysia, and India. Scholars and experts from all over the world are most welcome to submit their research results to the journal to promote academic exchange among experts internationally. Please visit the JFDA website at http://www.fda.gov.tw/TC/publishJFDA.aspx for free full-text downloading.

Cases# 289 and 293 are a couple; Case #293 traveled with a tour group to Spain and Portugal from March 7 and March 16, and was in home quarantine after returning to Taiwan. The couple developed symptoms on March 22 and March 23, respectively. Infection with COVID-19 was laboratory-confirmed in the cases on March 29. As Case #289 has no recent history of travel abroad, it is determined that the case was infected locally through close contact with Case #293 without taking proper preventive measures. The members of the couple’s family are awaiting test results.

Case #268 began to have symptoms on February 28 and sought medical care many times. The patient was hospitalized on March 20 and discharged on March 23 after symptoms improved. The patient sought medical attention again on March 25 for having a fever and shortness of breath, and then was tested for COVID-19 and reported to health agencies. Infection with COVID-19 was laboratory-confirmed in the case on March 28. A total of 102 individuals who had contact with the case have been preliminarily identified, and an investigation into the source of infection will be conducted. Case #269 sought medical attention for having muscle pain, diarrhea and a fever between March 23 and March 24. The patient was tested for COVID-19 and reported to health agencies on March 25. Infection with COVID-19 was laboratory-confirmed in the case on March 28. A total of seven contacts have been identified so far, and an investigation will be launched to identify the persons who had contact with the patient when the patient sought medical care. Additionally, the CECC continues to investigate the source of infection.

The CECC reminded members of the public in home quarantine/isolation to stay within designated quarantine area and turn on their mobile phone. During the home quarantine/isolation period, the individual can ask his/her family members, persons living together or online shopping services to help deliver food, other groceries or products necessary for daily activities. If the individual lives alone, the individual can contact the care and support center for quarantined/isolated individuals set up by each county/city government. If suspected symptoms, such as cough or fever, develop, the individual shall contact the local health bureau or the care and support center for quarantined/isolated individuals of each county/city government, which will arranged medical care. If the individual seeks medical attention for other chronic diseases, the individual can consult with the doctor via video call and ask his/her family members to collect medications. The individual is to postpone non-urgent medical care, including aesthetic medicine and health checkups until the end of home quarantine/isolation.

The CECC also reminded members of the public that those in violation of related measures will be fined up to NT$1 million and put in group quarantine.

Case #254 went to the United States for study in August of 2019, and visited a friend who also studied abroad in the United States (Case #218, displaying symptoms on March 17) from March 5 to March 19. Case #254 developed symptoms on March 20. When returning to Taiwan on March 24, the specimen of the patient was collected at the airport. Infection with COVID-19 was laboratory-confirmed in the case on March 27. Cases #257 and #258 studied in the same department of an education institution in the United Kingdom. Case #257 developed symptoms on March 10. When returning to Taiwan on March 24, the specimen of the patient was collected at the airport. Case #258 was in home quarantine after entering Taiwan on March 22. After Case #258 developed symptoms on March 23, health agencies arranged medical care for the patient who was then tested for COVID-19. Infection with COVID-19 was laboratory-confirmed in the case on March 27.

Cases #264 and #267 are a couple who traveled to the United Kingdom for work from March 8 and March 25. They had symptoms between March 20 and March 23. When returning to Taiwan on March 25, the specimens of the two patients were collected at the airport. Infection with COVID-19 was laboratory-confirmed in the cases on March 27.

Among the 15 imported cases, seven patients are women and eight patients are men, with their ages ranging between 20 and 69 years old. These patients entered Taiwan between March 16 and March 23 and displayed symptoms between March 11 and March 23. The countries these patients had traveled to before the onset of disease include Malaysia, Mexico, Monaco, New Zealand, Spain, the United Kingdom and the United States.

The CECC also reported that 931 additional cases related to coronavirus disease 2019 (COVID-19) were reported on March 24. As of writing, a cumulative total of 26,660 cases have been reported among which COVID-19 has been ruled out in 24,044. Of these reported cases, infection with COVID-19 was laboratory-confirmed in 235 cases (Cases #217-235 confirmed today). Of 235 confirmed cases in Taiwan, 197 are imported and 38 are indigenous. Of the confirmed cases, there have been 2 deaths, and 29 patients have been released from isolation while the remainder is in a stable condition and remains hospitalized in isolation.

With respect to Cases #222-225, the four patients studied abroad at the same education institution in the United Kingdom as Case #152. They were detected at the airport and reported to health agencies when entering Taiwan on March 22. Infection with COVID-19 was laboratory-confirmed in the cases on March 25. Related investigations suggest that it is a cluster infections on campus. Case #226 is a member of a travel group to Egypt. During the home isolation period, the patient had a dry throat on March 21, and health officials arranged medical care for the patient who was then tested for COVID-19. Infection with COVID-19 was laboratory-confirmed in the case on March 25. A total of ten individuals in the cluster involving the tour group have been diagnosed with COVID-19 (nine group members, one contact).

Case #233 visited the United Kingdom for study in December of 2019. The patient didn’t show any symptoms when arriving in Taiwan, and returned home for home quarantine. The patient developed symptoms on March 23. Health officials arranged medical care for the patient who was then tested for COVID-19. Infection with COVID-19 was laboratory-confirmed in the case on March 25. The remaining 13 cases are not linked to other confirmed cases.

Cases #197 and #202 are a couple who traveled to the United States to visit relatives from March 8 to March 18. The couple developed symptoms on March 19. Infection with COVID-19 was laboratory-confirmed in the cases on March 24. Related contacts are currently in home isolation. Case #213 visited Spain for study. When returning to Taiwan on March 13, Case #213 was on the same flight as the confirmed cases in the cluster involving a travel group to Egypt. As a result, the patient was identified as a related contact, and asked to self-isolate at home. The patient had symptoms on March 15, and tested positive for COVID-19 on March 24. All related contacts are currently in home isolation. 

With respect to the remaining 17 imported cases, most of the patients went overseas for study or work, while several of them went abroad for travel or visiting relatives.

The CECC pointed out that the online ordering procedures for the second round will be similar to those for the first round, with one notable difference being that the second round has been shortened, enabling those who order online to quickly collect their face masks. Key aspects of the second round are as follows:

1. People can place online orders from 08:00 on March 25 (Wed.) to 20:00 on March 27 (Fri.) by verifying their identity with their NHI card or Citizen Digital Certificate or through the NHI Administration’s National Health Insurance Express mobile app. 
2. Those who have successfully placed an online order will be requested to complete the related payment between 08:00 on March 28 (Sat.) and 20:00 on March 30 (Mon.) by ATM transfer or credit card.
3. Those who have successfully placed an online order and completed the payment will receive a text message on March 31 (Tue.) or April 1 (Wed.) with an order pickup number. 
4. The face masks can be collected from April 2 (Thu.) to April 8 (Wed.) with the order pickup number and ID of the person who placed the order (i.e., National ID Card, Resident Certificate, NHI card, driver’s license) at a designated convenience store. Simply input the order pickup number and ID number at the convenience store’s kiosk system (e.g., ibon, FamiPort, Life-ET, OK·go), print the pickup form, and give the form to store staff.

With respect to the only indigenous case confirmed today, the patient is an over-30-year-old female (Case #186). The female patient lives with Case #168, and is a contact of Case #168 which has been linked to a cluster in a research institution. She developed symptoms on March 17. As Case #124 was diagnosed with COVID-19 on March 20 and Case #168 also developed symptoms, Case #186 sought medical attention on her own and was tested for coronavirus on March 20. Infection with COVID-19 was laboratory-confirmed in the case on March 23. The patients is the fifth person in the cluster involving the research institution to be diagnosed with COVID-19.

Cases #160, #168 and #169 are contacts of Case #124. Case #160 traveled to the United States for work from March 1 to March 10. The patient went to a clinic for having a headache on March 14 after returning to Taiwan. The patient was listed as a contact of Case #124 on March 20, and was then tested for coronavirus. Infection with COVID-19 was laboratory-confirmed in the case on March 22.

With respect to the remaining 10 imported cases, most of the patients went overseas for study or work, while several of them went abroad for travel or visiting relatives.

Cases #143 and #144 are a couple who reside in the Czech Republic. The couple are relatives of Case #77(imported case). They were sent to the hospital for related testing when arriving in Taiwan on March 19. Infection with COVID-19 was laboratory-confirmed in the cases on March 21. Case #148 traveled to the United States for study from January 24 to March 15. Case #148 was on the same flight back to Taiwan as Case #85, and identified as a contact of Case #85. Case #148 developed symptoms on March 18. Infection with COVID-19 was laboratory-confirmed in the case on March 21. Case #150 is a member of Case #133’s family. The patient traveled to the United Kingdom for study from January 14 to March 14, and returned to Taiwan with Case #133 on March 14. Case #150 had symptoms on March 19. Infection with COVID-19 was laboratory-confirmed in the case on March 21. With respect to the remaining 13 imported cases, the patients are not linked to other confirmed cases and went overseas mainly for study or travel, with work being part of reason.

The CECC reiterates that upon returning to Taiwan, citizens must complete a Health Declaration Card and report any symptoms of illness to quarantine officers at the airport. It is essential that all inbound travelers abide by these measures to ensure the safety of the entire nation.

Case #103 is a classmate of Case #59. They both are high school students and sit near each other in the classroom. Their high school will be temporarily closed beginning March 20 until March 27 as two cases have been confirmed in the school. Cases #104 and #108 are an over-40-year-old female and an over-40-year-old male, who had traveled to Austria and the Czech Republic with the same tour group as Case #61. A total of four members of this tour group have been confirmed to have COVID-19. Case #105 is an over-20-year-old male. He went abroad alone on December 24 of 2019 to study in France. He returned to Taiwan on March 17. Members of his family currently don’t have any symptoms.

Case #106 is an over-20-year-old male. He traveled to Spain on a study tour from January 5 to March 17. Case #107 is a French male in his 50s. Case #107 visited his relatives in Taiwan on March 15, and was under home quarantine at a hotel designated by the local government upon entry. He developed symptoms on March 17. Infection with COVID-19 was laboratory-confirmed in the case on March 17. Health agencies will continue to trace related contacts of these cases.

With respect to 361 Taiwanese businessmen returning from Wuhan, China in second round of evacuation, 2 had fever and were sent to the hospital. One of the two individuals tested negative for COVID-19 twice while the other one is awaiting results. The remaining evacuees are currently healthy. The CECC will continue to closely monitor their health status. 

Given the risk of infection to Taiwanese nationals, effective March 19 the CECC will raise its travel notice for the US, Canada, Australia, and New Zealand, including for transit flights made through these countries, to Level 3: Warning. This comes in addition to the US states of Washington, New York, and California, which were already subject to a Level 3: Warning travel notice. Taiwanese nationals should avoid nonessential travel to these countries, and will be required to follow a 14-day period of home quarantine after returning from Level 3 countries and regions. Furthermore, effective March 19, all inbound travelers will be required to follow a 14-day period of home quarantine after entering Taiwan. 

As of March 18, the CECC has raised its travel notice for 97 countries and one region to Level 3: Warning; namely, mainland China (including Hong Kong and Macao), 20 Asian countries, nine Central Asian countries, 26 Schengen countries, the United Kingdom, the Republic of Ireland, 14 Eastern European countries, 16 countries and one territory in the Middle East, five north African countries, the US, Canada, New Zealand, and Australia. The Level 3 travel notice also applies to dependent territories of these countries where applicable. 

With respect to other confirmed cases, ten women and seven men were among the confirmed imported cases announced today. These 17 patients are between 20 and 59 years old, and developed symptoms between February 14 and March 16. These patients have travel history to different countries, including three visiting Spain; three visiting the United States; two visiting the United Kingdom; two visiting France; one visiting Indonesia; one visiting Qatar; one visiting the Philippines; one visiting Switzerland; and one visiting Germany. With respect to the remaining two patients, one of them had traveled to France, Spain and the United Kingdom while the other one had visited the United Kingdom, Italy and France. 

Regarding 2 indigenous cases confirmed today, one of the two patients is an over-20-year-old male, and the other one is an over-20-year-old female. The man in his 20s is a contact of the confirmed cases tied to the travel group to Egypt. The woman in her 20s has no recent travel history, and the source of infection has yet to be identified.

The CECC also announced that starting from March 19, entry of all foreign nationals will not be allowed unless documents of granted entry are provided and that inbound travelers will be subject to a 14-day period of home quarantine after entering Taiwan.

If you have device-related problems, please file reports electronically at http://qms.fda.gov.tw, or call the adverse reaction reporting line at 02-2396-0100.

The countries and US states covered by this announcement are as follows: 
    Asia: Bangladesh, Bhutan, Brunei, Cambodia, East Timor, India, Indonesia, Japan, Laos, Malaysia, Maldives, Myanmar, Nepal, North Korea, the Philippines, Singapore, Sri Lanka, Thailand, and Vietnam
    Eastern Europe: Moldova
    US states: California, New York, and Washington

The CECC has advised that all nonessential travel to the countries and areas listed above be avoided. Starting at 16:00, March 17, Taiwan time, travelers already on a flight from any of these countries or areas to Taiwan must observe a 14-day period of self-health management after entering Taiwan, while those boarding a flight after that time will be required to undergo a 14-day period of home quarantine. 

While only the above three US states have been listed at Level 3: Warning, the CECC has raised the travel notice for all other US states to Level 2: Alert. Travelers to Level 2 states are advised to take strong precautionary measures and will be required to observe a 14-day period of self-health management upon returning to Taiwan.

The CECC urged individuals who arrived from Europe during the time period of March 3 to March 14 to follow a 14- day period of self-health management upon returning to Taiwan. Such individuals are advised to temporarily stop attending classes or temporarily work from home.  

Case #71 is an over-60-year-old male who resides in northern Taiwan. Case #71 joined the same travel group to Egypt as Cases #55 and #63 from March 3 to March 12. He tested positive for COVID-19 on March 17. Case #71 is the third member of the tour group to be diagnosed with COVID-19. Case #72 is a woman in her 70s who resides in southern Taiwan. Case #72 traveled to Austria and the Czech Republic as part of a tour group with a member of her family (Case #61) from March 5 to March 14. Infection with COVID-19 was laboratory-confirmed in the case on March 17. Case #72 is the second person with confirmed COVID-19 among the members of the tour group.

Case #74 is an over-30-year-old male who resides in southern Taiwan. He visited Iceland with seven other members of his family from February 25 to March 10. Infection with COVID-19 was laboratory-confirmed in the case on March 17. Case #75 is an over-20-year-old male who resides in southern Taiwan. Case #75 visited Germany from February 23 to March 8. Infection with COVID-19 was laboratory-confirmed in the case on March 17. Case #76 is an over-30-year-old female who resides in northern Taiwan. Case #76 traveled to Paris with two other friends from March 1 to March 12, and tested positive for COVID-19 on March 17. Case #77 is an over-60-year-old female who resides in northern Taiwan. Case #77 left for the Czech Republic from Taiwan, transiting in Dubai, on January 20. She flew from the Czech Republic to New York to visit her family on March 7, and arrived in Taiwan on March 16. Case #77 tested positive for COVID-19 on March 17.

The countries and territory covered by this announcement are as follows: Afghanistan, Albania, Algeria, Armenia, Azerbaijan, Bahrain, Belarus, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Egypt, Georgia, Iraq, Israel, Jordan, Kazakhstan, Kosovo, Kuwait, Kyrgyzstan, Lebanon, Libya, Mongolia, Montenegro, Morocco, North Macedonia, Oman, Pakistan, Palestine, Qatar, Romania, Russia, Saudi Arabia, Serbia, Syria, Tajikistan, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, Uzbekistan, and Yemen. Travelers from these countries will be required to follow a 14-day period of home quarantine after entering Taiwan.

Case #61 is an over-50-year-old female who resides in southern Taiwan. Case #61 visited Austria and the Czech Republic with a tour group from March 5 to March 14. She had a fever when returning to Taiwan on March 14, and tested positive for COVID-19 on March 16. Preliminary investigation has identified a total of 20 individuals who had contact with the patient, including people in the same tour group. Furthermore, at least one of Case #61’s family member who traveled with her developed a fever on March 15, and is currently being treated in a negative pressure ward.

Case #62 an over-60-year-old female who resides in northern Taiwan. Case #62 visited her relatives in the Philippines with a member of her family from March 7 to March 14. She developed symptoms including fever and cough in the Philippines, and was tested for COVID-19 after returning to Taiwan on March 14. Infection with COVID-19 was laboratory-confirmed in the case on March 16. Two of her family members have no suspected symptoms. 

Case #63 is an over-50-year-old male who resides in northern Taiwan. Case #63 visited Egypt with the same tour group as Case #55 from March 3 to March 12. A total of 98 contacts related to this travel cluster have been identified so far. Except for Case #63 who tested positive for COVID-19, the remaining contacts haven’t developed suspected symptoms.

Case #64 is an over-20-year-old male who went to Spain for study in August, 2019. Case #64 decided to return to Taiwan as a confirmed case occurred on the campus. He arrived in Taiwan on March 12, and tested positive for COVID-19 on March 16. Cases #65 and #66 are two females in their 50s. Case #67 is an over-60-year-old male. Three patients reside in southern Taiwan. The three patients traveled to Turkey (with the same tour group as Cases #56 and #57) from March 4 to March 13. They began to develop symptoms on March 14, and were tested on March 15. Infection with COVID-19 was laboratory-confirmed in three cases on March 16. So far, a total of five individuals from the same travel group as Case #56 have been confirmed to have COVID-19. The CECC continues to trace other individuals having contact with the cases.

Given the risk to Taiwan nationals of infection, the CECC has raised the travel notice for Egypt to Level 2: Alert starting today and reminded travelers visiting Egypt to practice enhanced precautions.

Case #55 is an over-50-year-old male who resides in northern Taiwan. Case #55 joined a travel group to Egypt from March 3 to March 12. Case #55 is currently being treated in a negative pressure isolation ward. Preliminary investigation has identified a total of 33 individuals who had contact with the case, including people in the same tour group and persons having contact with the case at the hospital.

Cases #56 and #57 are an over-40-year-old male and an over-70-year-old female, respectively. Both patients reside in northern Taiwan. Both cases traveled to Turkey as part of a tour group, transiting through Dubai, from March 4 to March 13. Infection with COVID-19 was laboratory-confirmed in the two cases on March 15. Preliminary investigation has identified a total of 19 individuals who had contact with the two patients, including people in the same tour group and family members living with them.

Case #58 is an over-20-year-old female who resides in norther Taiwan. Case #58 went to Spain for study in January, and returned to Taiwan on March 13. She tested positive for COVID-19 on March 15, and is being treated in a negative pressure isolation ward. Preliminary investigation has identified a total of 5 individuals who lived with her and had contact with the case.

Case #59 is a male in his teens who resides in northern Taiwan. Case #59 visited Greece with his family in January, and returned to Taiwan on March 5. Preliminary investigation has identified a total of 16 individuals who l had contact with the case. The CECC continues to trace other individuals having contact with the cases.

The disease outbreak in the US has intensified, with 46 states and Washington D.C. all reporting confirmed cases, and more than 20 states having declared a state of emergency. According to the assessment of the US Centers for Disease Control and Prevention(CDC), coronavirus disease 2019 (COVID-19) is spread through communities in the states of Washington, New York and California. Isolation measures have been implemented in certain regions suffering from severe epidemic developments. In light of the situation, the CECC raised its travel notice for the above three states to level 2: Alert. Travelers visiting these regions are advised to practice enhanced precautions. The travel notice for remaining US states is Level 1: Watch, and visitors are advised to take usual precautionary measures. 

The World Health Organization (WHO) declared COVID-19 a pandemic, with more than 110 countries reporting confirmed cases and more than 70 countries reporting indigenous transmissions. Various countries have strengthened its border control measures and restricted the movement of people. As infections continue to spread globally, and considering the close transportations and exchange between nations, the CECC raised its travel notice to Level 1: Watch, for all countries yet listed in the advisory. Travelers who have visited countries listed in the Level 1 and 2 categories in the past 14 days are required to practice a 14-day self-health management. As travel notice are heightened for countries around the globe, the government will strengthen its border control measures and conduct retrospective screenings to ensure the safety of Taiwan people. 

Case #52 is an over-30-year-old Taiwanese male who resides in northern Taiwan. Case #52 transited through Turkey for Switzerland from Taiwan with his two other friends on February 28. He traveled to France from Switzerland on February 29, and took a bus back to Switzerland to catch his flight on March 7. He transited in Turkey, and returned to Taiwan on March 8. He sought medical care for his symptoms, and was tested and reported to health agencies on March 12. Infection with COVID-19 was laboratory-confirmed in the case on March 14. Case #52 is being treated in a negative pressure isolation ward. Preliminary investigation has identified a total of 39 individuals who had contact with Case #52, including his friends, passengers on the same flight back to Taiwan and persons having contact with the case at workplace and the hospital.

Case #53 is an over-30-year-old Taiwanese male who resides in northern Taiwan. Case #53 visited Munich and Nuremberg, Germany from February 22 to March 6. He sought medical attention for his symptoms, and was tested and reported to health agencies on March 11. Infection with COVID-19 was laboratory-confirmed in the case on March 14. Case #53 is being treated in a negative pressure isolation ward. Preliminary investigation has identified a total of 15 individuals who had contact with Case #53, including his colleagues, his family and persons having contact with the patient at workplace and the hospital. The CECC will also investigate activities Case #53 had done before the onset of symptoms to further trace persons with potential contact with him.

The CECC reminded travelers traveling abroad to reinforce respiratory as well as hand hygiene; and travelers returning to Taiwan to abide by 14-day period of home quarantine or self-health management measures.

With respect to the four American friends Case #50 hosted on February 24, one developed chills, cough and tiredness on February 24, and the person’s partner also showed symptoms after leaving Taiwan on February 26. Moreover, at least a member of this couple’s family in the United States was later diagnosed with COVID-19. One of the other two American friends also developed respiratory symptoms after leaving Taiwan on February 26. Based on Case #50’s exposure history before the onset of symptoms, there is a higher possibility that Case #50 was infected with the novel coronavirus via contact with his friends from the United States.

In response to the continued spread of COVID-19, the CECC announced today that it has raised the travel notice to Level 2: Alert for the following European and Middle Eastern nations: Austria, Bahrain, Belgium, Denmark, Iceland, Kuwait, the Netherlands, Norway, Sweden, and Switzerland. Visitors to these areas are advised to take enhanced precautionary measures, and travelers returning to Taiwan from any of the countries listed above must observe a 14-day period of self-health management.

Additionally, in consideration of the substantial people flows within the Schengen Area, the CECC has raised the travel notice to Level 1: Watch for the following countries: the Czech Republic, Estonia, Finland, Greece, Hungary, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Poland, Portugal, Slovakia, and Slovenia. Due to the ease of travel to and from the Schengen Area, the travel notice for Ireland and the United Kingdom has also been raised to Level 1: Watch. The CECC reminds visitors to the countries listed above to take usual precautionary measures. Travelers to any of the aforementioned countries must observe a 14-day period of self-health management upon their return to Taiwan.

The government has been working tirelessly with the private sector to develop and test the new mechanism, which serves as an addition to existing distribution channels, i.e., pharmacies contracted by the National Health Insurance Administration and local public health centers. The mechanism will allow people to order at a designated website using their NHI card or Citizen Digital Certificate or through the NHI app.

The CECC further explained that the first round of online orders beginning on March 12 will constitute a trial run, with an estimated seven million face masks (equal to the weekly allotment of 2.33 million people) being made available. Key aspects of the online ordering mechanism are as follows:
1.    The first round of online order registration ends on March 18. Restrictions with regard to National ID Cards and Resident Certificates ending in odd or even numbers do not apply.
2.    Those who have successfully ordered face masks online will receive a payment notification via text message March 19 with instructions to complete the payment within a specified period of time. (Payment methods include ATM, online banking, and credit card).
3.    Those who have successfully ordered and paid for face masks can pick them up at convenience stores from March 26 to April 1 with their NHI card or proof of purchase certificate issued by the online ordering mechanism. (Those picking up face masks for others must present these same documents.) Orders not picked up by April 1 will be canceled.
4.    If the number of people ordering face masks online exceeds the anticipated number listed above, lots will be drawn publicly the day after the registration period ends. The distribution of face masks ordered online is not done on a first come, first served basis; there is no need to rush and register online on the first day.
5.    Rules for online purchases will be the same as for purchases through existing channels. During the trial period of the online ordering mechanism, only adult face masks will be made available, with each adult being eligible for three face masks every seven days and each mask costing NT$5.
6.    Those wishing to order face masks with their NHI card or Citizen Digital Certificate need a computer, internet connection, and card reader.
7.    Each online order comes with a NT$7 delivery fee, to be paid by the person submitting the order.

The CECC pointed out that the trial period is for face masks to be distributed in the week from March 26 to April 1. The online ordering mechanism may be adjusted depending on the results of the trial period. People who do not wish to wait for the distribution of face masks ordered online can still purchase face masks at NHI-contracted pharmacies and local public health centers as before.

The CECC indicated that Case #46 has no recent travel history and lives with Case #34 and Case #41 and that Case #46 had kept Case #34 company in the hospital. After Case #34 was diagnosed with COVID-19, Case #46 was placed in isolation in the hospital and tested twice for COVID-19 from February 28 to March 3 as he had contact with Case #34. Case #46 returned home for home isolation after having tested negative for COVID-19. He had a cough from March 6 to March 8. As health agencies conducted related health follow-up, Case #46 reported a worsening cough. Case #46 was then admitted to a negative pressure isolation ward and tested for the novel coronavirus for the third time. He tested positive for COVID-19 on March 10. With respect to the cluster, a total of 447 contacts have been identified, and 398 individuals have been tested. Of these contacts, 8 tested positive for COVID-19 (Cases #35-38, and Cases #41, #42, #45 and #46), and 386 tested negative with the remainder awaiting test results.  

The CECC also reported that Case #47 went on a business trip to the Netherlands with two other colleagues from March 2 to March 5. After returning to Taiwan, Case #47 developed a mild fever and a dry cough on March 9, and he sought medical care the same day. As the patient has a travel history and developed symptoms, the hospital reported the case to health agencies. The patient was diagnosed with COVID-19 on March 10. Case #47 is being treated in a negative pressure isolation ward. Based on the locations he had visited before the onset of the symptoms, there is a higher possibility that Case #47 had contracted the novel coronavirus abroad. Health agencies will investigate Case #47’s travel itinerary in the Netherlands, and continue to follow up on the health of passengers on the same flight as Case #47, his family and friends, his colleagues and other persons who had contact with him.

Upon the receipt of the notification of the suspected case from the Palau government, Taiwan’s responsible authorities invited physicians from the Shin Kong Hospital to provide assistance in collecting the case’s specimens via video conferencing technology, and arranged transport for the specimens. The specimens arrived in Taiwan on the evening of March 6, and were sent to labs at Taiwan Centers for Disease Control for further testing. Health authorities will notify Palau and the United States of test results.  

The CECC reported that it has launched an investigation into individuals having contact with Case #45. A total of 417 contacts related to the cluster have been identified so far. Of 417, 346 individuals have tested for COVID-19. Of 346, 7 tested positive (Cases #35-38 and Cases #41, #42 and #45), and 330 tested negative with the remainder awaiting results.  

The CECC indicated that even though the traveler had cough before entering Taiwan, the traveler didn’t travel to any regions affected by COVID-19. The Australian traveler was asymptomatic upon arriving in Taiwan on February 23; thus, it is determined that the traveler was infected with the novel coronavirus abroad. While the traveler’s stay in Taiwan, the traveler took part in a rehearsal at a concert hall, developed a cough and a runny nose, and went to a clinic on the evening of February 27. He performed in the concert hall on February 28 and March 1, and left Taiwan on March 2.

The CECC has identified related contacts based on the travelers’ itinerary in Taiwan. Related close contacts will be subject to a 14-day period of home isolation while other contacts will be subject to a 14-day period of self-health management. The CECC also stated that as the audience at the musical performance was seated far away from the Australian traveler, the risk of infection is very low for the audience. The public is advised to remain calm.

The CECC stated that preliminary investigation suggested a higher possibility that the patient contracted the novel coronavirus abroad, and developed symptoms in Taiwan. The CECC is investigating the patient’s travel itinerary in Taiwan from February 23 to March 2 to identify related contacts. The public is advised to remain calm.

Case #44 is an over-30-year-old male who resides in northern Taiwan. He traveled to the Philippines with his friends from February 28 to March 3. He had diarrhea in the Philippines on March 2. After he returned to Taiwan, Case #44 went to a clinic due to having a dry throat and tiredness on March 3. He went to a hospital and was reported as a suspected case on March 4. Infection with COVID-19 was laboratory-confirmed in the case on March 5. Related investigation suggested it is an imported case linked to the Philippines.

As the COVID-19 epidemic continues to expand internationally, the CECC has listed China (including Hong Kong and Macau), South Korea, and Italy and Iran under travel notice Level 3: Warning; Japan and Singapore under Level 2: Alert; and Thailand under Level 1: Watch. The CECC will continue to closely monitor the developments of the epidemic and adjust its disease prevention strategy and travel notices for countries as the situation requires. 

February 17   
Traveling from Toyama Prefecture to Takayama City 

Feburary 18 
Takasu Snow Park of Gifu Prefecture

February 19 
Toyama Prefecture; taking JR Thunderbird express train from Takaoka to Osaka (Route: Kanazawa to Osaka) 

February 20  
Universal Studio in Osaka

February 21-22
Downtown area in Osaka

67 people having contact with Case #33, including tourists of the same travel group, friend(s) living together, and colleagues have been identified. Three of them who had symptoms have been hospitalized in quarantine and tested for coronavirus disease 2019 (COVID-19). The remainder will be placed under home quarantine for 14 days and be tested.

As of February 28, a total of 2,105 cases have been reported, including 39 confirmed cases. (Five new confirmed cases were reported today, Cases #35-39.) Of these reported cases, COVID-19 has been ruled out in 2,050 individuals. The remainder is under quarantine, and awaiting results (preliminary tests were negative in 12, and the rest are waiting for tests.)

Among the confirmed cases, there are one death, nine discharged from the hospital, and the remainder hospitalized.

Case #35 had contact with Case #34 while working at the emergency department. Cases #36, #37 and #38 were healthcare staff who took care of Case #34 before the index patient tested positive for COVID-19. The four patients began to develop symptoms, including coughing, a runny nose and fever, from February 18 to 25. After they were identified as contacts of Case #34, they tested for COVID-19. Their test results came back positive on February 29. Their infections suggested a cluster, and the CECC has reinforced its active surveillance on the hospital.

Case #39 is a female in her 60s residing in northern Taiwan. She traveled to Dubai and Egypt with friends and family members from January 29 to February 21. There were 36 people in the same travel group including Case #39. She developed a sore throat and cough while traveling in Egypt on February 20. After returning to Taiwan, Case #39 went to a clinic on February 21. Her cough got worse on February 26, and she also had symptoms such as chest tightness, abdominal pain and vomiting the same day. She sought medical attention and tested for COVID-19 on February 28. She was diagnosed with COVID-19 today. 
 

In response to the international spread of COVID-19, the CECC has listed China (including Hong Kong and Macao), South Korea, and Italy under travel notice Level 3: Warning; Japan, Singapore, and Iran under Level 2: Alert; and Thailand under Level 1: Watch. The CECC will continue to closely monitor outbreak developments and adjust its prevention strategy and travel notices as the situation requires. 

＊Past Activity of Case #32

Feb. 16
18:00  Took a taxi to Dapinglin Metro Station and rode the MRT to Taipei Main Station
18:46  Took a train to Shulin Railway Station
19:34  Took Blue 38 bus to Dongsheng Park and then returned home

Feb. 17
15:07    Took Blue 38 bus to Shulin Railway Station
15:09    Train arrived at Taipei Main Station
15:42    Visited Taipei City Mall (underground mall)
16:42    Rode the MRT Red Line to Zhuwei Station
17:14    Reached Minzu Road and then returned to Zhuwei Station. Rode the MRT to Shilin Metro Station.  
18:32    Shortly after leaving Shilin Station, she rode the MRT Red Line and transferred to Blue Line to Longshan Temple Metro Station 
19:06    Strolled around Section 1, Xiyuan Road, Wanhua District and shopped around Longshan Temple Metro Station. She then rode the MRT Blue Line to Taipei Main Station
20:40    Walked to a nearby hotel and stayed there for the night.

Feb. 18
10:32    Checked out and took a train to Shulin Railway Station
11:16    Took Blue 38 bus to Dongsheng Park and then returned home
12:36    Took Blue 38 bus to Shulin Railway Station
12:39    Went shopping around Shulin Railway Station
13:00    Took a train to Banqiao Station
13:20    Saw friends off at the Banqiao Station and took Taiwan High Speed Rail Train No. 133 to Kaohsiung; took a train to Shulin Railway Station (time of arrival:13:51) 
14:05    Took Blue 38 bus to return her home in Shulin

Feb. 19
8:52      Took Blue 38 bus to Shulin Railway Station
9:00      Took a train to Taipei Main Station
9:33      Rode the MRT Orange Line to Jingan Metro Station
10:02    Took a taxi to the hospital to take care of a new patient. Stayed in the hospital until Feb. 24

Food additives were mostly natural substances in the beginning. For example, berries naturally contain benzoic acid, propionic acid could be found as produced during the fermentation of cheese, and acetic acid can also be produced by the fermentation of vinegar. These acids not only impart special flavor to food, but also, due to the decrease in pH, suppress the growth of microorganisms and extend the storage time of food. Both of nucleotide phosphates (such as Sodium 5'–Inosinate and Sodium 5'–Guanylate) found in foods such as mushrooms and fish and glutamic acid found in kelp can enhance the umami taste of food.

Food additives are used for many purposes. For example, nitrite added in sausages can help maintain a bright red color in meat, and also prevent botulism poisoning; vitamin E added in oil can prevent oil oxidation; leavening agent in biscuits and muffins help enhance the texture; thickening agent in sauces increases the adhesion and body; sweeteners let those who are not suitable for sweets enjoy sweet foods. All in all, in addition to maintaining the sensory characteristics and quality of the food, the more important thing is to ensure food safety.

Countries around the world set standards governing the use of food additives to regulate their scope, limitation, and specifications. “The Standards for Specification, Scope, Application and Limitation of Food Additives” of R.O.C. are made and promulgated after referring to animal safety studies, to relevant international regulations and standards and their applications, to the physical and chemical characteristics of various food additives, to the use of additives after being processed and its necessity, to the documents on the foods, scope, processing procedure, and the amount of use of the additives, and considering the conditions of the dietary habits and health risks of the citizens, and making careful evaluation on them. Legal use of food additives should not cause harm to consumers' health provided that business operators make reasonable use of the food additives and strictly follow the above-mentioned standards.

Careful use of food additives can ensure the quality and safety of food. The most important principle is to use them legally and reasonably. In using the food additives, the business operators shall consider their product formulas and follow the “Standards for Specification, Scope, Application and Limitation of Food Additives”, and shall provide as evidence the product formulas, the processing procedures, and related quality assurance information, and label their products in accordance with the provisions of the “Act Governing Food Safety and Sanitation”.

There have been 95 confirmed COVID-19 cases and 15 deaths in Iran so far, with cases reported across 13 provinces. Iran has the highest number of deaths from the novel coronavirus outside China, and cases in Oman, Iraq, Kuwait, the United Arab Emirates, and Canada have also been linked to Iran. Moreover, multiple countries across the Middle East have closed their borders with Iran. Based on the risk of COVID-19 infection in Iran, the CECC has adjusted its travel notice for the country as mentioned above.
 
The CECC stated that in response to the international spread of the COVID-19 outbreak, it has listed China (including Hong Kong and Macao) and South Korea under travel notice Level 3: Warning; Japan, Singapore, Italy and Iran under travel notice Level 2: Alert; and Thailand under Level 1: Watch. The CECC will continue to closely monitor outbreak developments and adjust the listing of affected areas and travel notices when necessary.

As Case #32 is a temporary caregiver, health agencies had launched an investigation into the patient’s activities from February 16 through 24, and identified other patients the case-patient took care of, patients sharing the same hospital ward and their caregivers during the period as contacts to have these contacts tested for COVID-19, the CECC stated. 

The CECC indicated that with respect to the cluster linked to Case #27, a total of 744 contacts had been established, of which 153 had tested. Of 153, five individuals tested positive (Cases #28, #29, #30, #31 and #32), and 141 tested negative, with the remainder awaiting results.

There have been 229 confirmed COVID-19 cases and six deaths in Italy so far. For many cases, authorities have been unable to pinpoint the source of infection, while a cluster of infection has been reported at a local hospital. The Lombardy (home to the city of Milan) and Veneto regions have temporarily banned all religious activities and large-scale gatherings. Schools at all levels have been suspended for a week, and more than 10 towns have been put on lockdown.

The CECC stated that in response to the international spread of the COVID-19 outbreak, it has listed China (including Hong Kong and Macao) and South Korea under travel notice Level 3: Warning; Japan, Singapore, and Italy under travel notice Level 2: Alert; and Thailand and Iran under Level 1: Watch. The CECC will continue to closely monitor outbreak developments and adjust the listing of affected areas and travel notices when necessary.

The CECC reminded the public that even though the distribution of child-size face masks has been modified, the rules for purchasing adult face masks remain the same. Each person is allowed to purchase adult face masks on behalf of another person at one time by presenting the person’s NHI card, and shall do so according to the rules for purchasing masks based on the ID number. 

With respect to this COVID-19 family cluster, a total of 580 contacts had been identified, of which 144 had tested. Of 144, four individuals tested positive (Cases #28, #29, #30 and #31), and 122 tested negative, with the remainder awaiting results, the CECC indicated today.

In addition, the CECC announced that starting from February 25, foreign nationals entering Taiwan from South Korea must undergo a 14-day period of home quarantine; that starting from February 25 until the end of February 26, Taiwanese nationals entering Taiwan from South Korea must conduct a 14-day period of self-health management; and that starting from February 27, Taiwanese nationals entering Taiwan from South Korea must undergo a 14-day period of home quarantine.

The CECC has utilized smart technologies to help track people under home quarantine to ensure the measure to be followed, the CECC stated today. 

Individuals subject to home quarantine shall maintain hand hygiene, wash hands frequently, keep one meter away from person(s) sharing the same household and avoid contact with the person(s). If symptoms including fever and cough develop, individuals shall not seek medical attention by themselves and shall contact health authorities to arrange their medical care. Those who violate relevant requirements for home quarantine by going outside will be fined up to NT$150,000.

Case #30 went to see a doctor due to physical discomfort on February 6, and was diagnosed with having acute pharyngitis. He sought medical attention four times for respiratory symptoms from February 10 to 19. As he was identified as a close contact of Case #27, his sample was collected on February 23. He tested positive for COVID-19 on February 24. He currently doesn’t have a fever or any discomfort and is being treated in an isolation ward.

Iran has seen a rapid growth in COVID-19 cases in recent days, with six deaths from the virus; cases in Lebanon, the United Arab Emirates, and Canada have also been linked to Iran. In Italy, as of February 22, authorities had reported 52 confirmed COVID-19 cases. The number of confirmed cases has grown rapidly in Lombardy, where Milan is located, including a cluster of infections at a hospital. Authorities have announced school closures, and suspended public activities and public transportation services in designated areas. Based on the risk of COVID-19 infection faced by travelers to Iran and Italy, the CECC has raised its travel notice level to Level 1:Watch for these countries. Travelers to Iran and Italy are advised to practice usual precautions. Medical personnel are advised to postpone any travel plans for these two countries.

Under close coordination between the Environmental Protection Administration and the Ministry of Education (MOE), local environmental protection departments have been tasked with disinfecting public spaces surrounding schools and public kindergartens and spaces within them which were open to the general public during the winter vacation, such as large hallways, wash basins, restrooms, and playgrounds. These disinfection tasks are scheduled to be completed by February 23.

In addition to cooperating with local authorities for the aforementioned disinfection activities, the CECC reminds schools and public kindergartens to institute appropriate cleaning and disinfection procedures for their classrooms and school buses. With regard to disinfection of indoor spaces, schools are advised to pay particular attention to points of frequent contact such as doorknobs, tables, and light switches. Cleaning and disinfection of school buses should be done in accordance with standards set by the Ministry of Transportation and Communications (MOTC) and guidelines announced by the Taiwan Centers for Disease Control for public transportation in response to the coronavirus disease 2019 (COVID-19) outbreak. Points of frequent contact such as seats, armrests, and grab handles should be properly cleaned and disinfected before and after shifts, so as to protect the health of students. 

Apart from measures for the schools and public kindergartens described above, the MOE will oversee universities and colleges in commissioning licensed companies to conduct cleaning and disinfection work on their campuses, to be completed before the start of the upcoming semester.

In anticipation of increased public transportation ridership at the start of the new semester, the MOTC has instructed operators to step up disinfection measures. Carriages of the Taiwan High Speed Rail (THSR) and Taiwan Railways (TR) should be cleaned and disinfected at least once a day; points of frequent contact inside THSR carriages (e.g., armrests, tables) once each round trip; and points of frequent contact in metro carriages once every eight hours. TR carriages should also be thoroughly disinfected when they return to their designated depots. Instructions have also been issued for city and long-distance buses to be disinfected before and after shifts each day, and once every eight hours during operation. The same requirements apply to tour buses and taxis during operation.

The CECC also calls on all citizens to regularly wash their hands with soap, ensure proper ventilation in their homes, and regularly clean their homes’ interior and exterior, so as to protect their health and that of their families.

With respect to the family cluster in the middle part of Taiwan, as of now, specimens of 217 contacts have been collected. Of 217, four (one additional case being the 60-year-old younger sister of the 19th confirmed case) have been diagnosed with COVID-19, while 189 tested negative and 24 are being tested, the CECC announced on February 19.
 

     The contact tracing initiated by the health agency found that the 21st case developed symptoms February 6, and the 22nd case had a fever and cough from January 28 to February 6. The two patients were confirmed infected with COVID-19 after lab tests today (February 17). As 22nd case don't live with the other 3 family members, the case is believed to be contracted from the index case at a family reunion during the Lunar New Year holiday, and thus it is determined to be a family cluster.

     As more cases without relevant travel history have been reported in neighboring countries such as Singapore and Japan, after discussing with experts, the CECC decided to make the resolution requiring severe complicated influenza cases reported by healthcare facilities on and after January 31 and tested negative for influenza to be tested for COVID-19 starting February 12. As of February 15, 113 tissue specimens have been tested, and the patient was the only case tested positive for COVID-19, indicated by the CECC.

     The second confirmed case is a male in his 50s, a member of the first case’s family. He was confirmed infected with COVID-19 after lab tests February 15. So far, this patient shows no symptoms of COVID-19, and is being treated in a negative pressure isolation ward.  

Since February 12, COVID-19 testing has become a mandatory procedure for severe cases with complications of influenza, cases of community-acquired upper respiratory infections under surveillance and clusters of upper respiratory infections who were reported on and after January 31 and whose specimens tested negative.

People who don’t require hospitalization as determined by the physician are required to return home to conduct self-health management and to stay at home before the notification of test results. Furthermore, people are advised to abide by self-health management regulations within 14 days of symptom onset. The CECC reminds that doctors should take droplet and contact precautions when admitting and treating suspected cases for further examination. For more information on COVID-19, please visit the Taiwan CDC website at http://www.cdc.gov.tw

People under home quarantine are considered to be contributing to prevention efforts at home. Responsible personnel contacts those people daily to learn about their health conditions after they return home. People under home quarantine are not suspected cases. If symptoms develop, health agencies will make medical arrangements. Therefore, the public is advised to remain calm and give support to encourage people required to go through home quarantine to abide by the measure as required.
 
The Central Epidemic Command Center (CECC) urged that people under home quarantine shall wash hands thoroughly, refrain from touching eyes, nose and mouth with hands and pay attention to cough etiquette. Travelers arriving in Taiwan are advised to voluntarily inform the quarantine officer at the airport/port and cooperate in following each prevention measure if symptoms such as fever and cough develop after returning to Taiwan. If suspected symptoms develop within 14 days after returning to Taiwan, please call the toll-free Communicable Disease Reporting and Consultation Hotline, 1922 (or 0800-001922) and put on a surgical mask and seek immediate medical attention as instructed. Moreover, please inform the physician of any history of travel, occupation, contact, and cluster (TOCC) to facilitate timely diagnosis and prompt case-reporting. For more information on 2019-nCoV, please visit the Taiwan CDC website at http://www.cdc.gov.tw.

With respect to the Taiwanese businesspeople evacuated from Wuhan, China on February 3, one evacuee was confirmed with 2019-nCoV on February 4 while the other 246 are under quarantine and being monitored at the quarantine site.

1. Two masks can be purchased per national health insurance (NHI) card at a time at a price of NT$10. Each person is allowed to make a purchase every seven days. Another purchase can be made 7 days after last day of purchase. For instance, if a person buys two masks on February 16, he/she will be allowed to make another purchase after February 23 and so forth.)
2. To reduce the queue for face masks, people whose ID numbers end with an even digit can buy masks on Tuesdays, Thursdays and Saturdays, while Mondays, Wednesdays and Fridays are for those with odd-digit last numbers on their ID. On Sundays, anyone can buy masks. (Zero is an odd digit).
3. Child size masks are only allowed to be purchased when NHI cards of children under 12 are presented (including those born after 2008 regardless of their birth months and days). People presenting NHI cards of children at the age of 13 or above are only allowed to buy adult face masks.
4. People presenting NHI cards of children under 12 can choose to buy adult face masks or child size masks as needed.
5. Only one purchase by proxy can be made per person. If a person does not buy masks for himself/herself, the person is only allowed to make one purchase by proxy and do so according to the abovementioned four rules.
6. Foreign nationals without a NHI card can buy masks by presenting a valid Alien Resident Certificate and following the abovementioned five rules.

To alleviate the effects of cold weather and the sharp temperature differences between day and night, HPA reminds that the elderly population, people with cardiovascular disease, and those with the so-called three "highs" — high blood pressure, lipids and sugar— to take their medication regularly, make follow-up visits back to clinics, and maintain a healthy diet. Also, people are advised to regularly measure and record their blood pressure levels as well.

Cardiovascular events such as heart attacks and strokes could be fatal, but seeking medical assistance early could lower the risks of death and disability. If someone shows any of these symptoms, please call 119 or emergency medical services immediately.

1. Heart disease symptoms: Cardiovascular disease symptoms may be different for men and women. For instance, men are more likely to have chest pain, difficulty breathing and dizziness; women are more likely to have other symptoms along with chest discomfort, such as nausea, hand numbness, backaches and difficulty breathing.

2. During a stroke, every minute counts! Fast treatment can lessen the brain damage caused by stroke. Use the FAST test to check for the most common symptoms of a stroke in yourself or someone else.

   Face: Smile and see if one side of the face droops.

   Arms: Raise both arms. Does one arm drop down?

   Speech: Say a short phrase and check for slurred or strange speech.

   Time: If the answer to any of these is yes, call 119 right away and write down the time when symptoms started.

The CECC reminded that although the monitoring period required for the incident has ended, the public is advised to maintain good personal hygiene and pay close attention to their own health conditions. If fever and respiratory symptoms develop, please wear a face mask to seek medical attention and inform the physician of relevant history of travel and contact.

Upon their arrival in Taiwan, travelers from China, Hong Kong and Macau (including those transiting through these areas) are provided the Novel Coronavirus Health Declaration and Home Quarantine Notice to complete by quarantine officers. After the launch of this online system, travelers with mobile phone numbers provided by telecom operators in Taiwan can use the Entry Quarantine System by scanning the QR Code while waiting at the check-in counter, the CECC pointed out. Travelers can complete the health declaration form online while waiting for their flights or upon entry. The health declaration pass will be sent to travelers’ mobile phone via SMS upon arrival in Taiwan. After that, travelers will get faster immigration clearance by showing the health declaration pass. Therefore, travelers can complete health declaration and get faster immigration clearance with 4 simple steps: scan the QR Code, fill out the form, get health declaration pass via SMS, and show the pass on your mobile phone.

The CECC indicated that there are 1,458 passengers in total on board the MS Westerdam. Two of these passengers are Taiwanese nationals while the other ones are foreign nationals or Chinese, Hong Kong or Macau nationals. Two Taiwanese nationals on board the cruise ship will be allowed to enter Taiwan and sent to a hospital for sample collection. If they test positive for coronavirus disease 2019 (COVID-19), two Taiwanese passengers will continue to be hospitalized in isolation wards for medical treatment. If tests come back negative, the passengers can return home to conduct self-health management for 14 days. Furthermore, no passengers will be seated in the same row, and at least two rows in front of and behind the two Taiwanese passengers on the plane. Foreign travelers are temporarily prohibited from entering or transiting through Taiwan. 

With respect to the Taiwanese businesspeople evacuated from Wuhan, China on February 3, one evacuee was confirmed with 2019-nCoV on February 4, and two are hospitalized in isolation. The CECC is continuing to closely monitor the health status of 244 people under quarantine.

The CECC reiterated that if individuals are notified of being identified as contacts of a case by the responsible health unit or enter Taiwan from China, Hong Kong and Macau, such individuals are required to abide by home isolation or home quarantine measures as instructed by the government. Violators of home isolation regulations will be fined up to NT$300,000. Violators of home quarantine regulations will be fined up to NT$150,000.  

In order to strengthen Taiwan’s border quarantine measures, starting today (Feb. 11), all travelers arriving from areas outside China, Hong Kong and Macau will be required to complete a health declaration form and accurately provide their travel and contact history regarding whether they have visited China, Hong Kong and Macau over the past 14 days before entry. If travelers provide inaccurate information or refuse, evade or interfere with the provision of such information, violators will be fined up to NT$ 150,000 according to relevant laws. With respect to travelers arriving from China, Hong Kong and Macau, the travelers are required to complete the Novel Coronavirus Health Declaration and Home Quarantine Notice and abide by home quarantine measures within 14 days after entering Taiwan.

With respect to the Taiwanese businesspeople evacuated from Wuhan, China on February 3, as of writing, one evacuee was confirmed with 2019-nCoV, and five are hospitalized in isolation. CECC will continue to closely monitor the health status of 241 people under quarantine.

With respect to 247 Taiwanese businessmen evacuated from Wuhan, China on Feb. 3, one evacuee was confirmed with 2019-nCoV on Feb. 4. As of 10am on Feb. 7, 8 evacuees developed respiratory symptoms among the other 246 evacuees. Among the 8 evacuees, 5 evacuees were sent to the hospital (2 cases are tested negative in preliminary tests and the other 3 cases are awaiting tests). The other 3 evacuees with respiratory symptoms are placed under quarantine and being monitored. CECC will continue to closely monitor the health of all people under quarantine.

Pursuant to the request proposed by the Ministry of Health and Welfare, Taiwan for disease prevention, the Ministry of Transportation and Communications will impose a temporary ban on cross-strait passenger flights between Taiwan and certain airports in China starting 0:00 am of February 10 to 11:59 pm of April 29. Except for the flights to and from Beijing Capital International Airport, Shanghai Pudong International Airport, Shanghai Hongqiao International Airport, Xiamen Gaoqi International Airport and Chengdu Shuangliu International Airport, cross-strait flights to and from the remaining airports in China will be suspended. 

Case #3 is a female in her 40s living in southern Taiwan. She traveled to Macau with three other family members from January 21 to 24. The case developed symptoms, including fever, chills, sore throat, running nose and shortness of breath on exertions on February 1. She sought medical attention on February 3 but didn’t meet the criteria of case reporting after the medical examination, and then she returned home. Since her symptoms lingered, the patient sought medical attention again and was placed in a negative pressure isolation ward, and her samples were also collected. The patient was later tested positive for 2019-nCoV. The case is currently in a stable condition and receiving medical treatment.

As of writing, a total of 16 confirmed cases have been reported in Taiwan. As of 4 pm on January 6, 21 additional cases of 2019-nCoV were reported. As of writing, a total of 1,307 cases have been reported, including 16 confirmed cases, 1,166 individuals removed from the follow-up list, 82 individuals with negative preliminary test results and the others awaiting tests.
 

According to the statistics collected by CECC, 55 additional cases of 2019-nCoV infection were reported in Taiwan on February 5, 2020. As of writing, a cumulative total of 1,290 cases have been reported, including 13 confirmed cases, 1,135 individuals removed from the follow-up list, and the remaining ones under quarantine for lab tests of who preliminary tests were negative in 98 and the others are awaiting tests. 13 confirmed cases are in a stable condition and being treated in isolation in the hospital. The contacts of the first confirmed cases have been removed from the tracing list, except that one contact tested positive for the coronavirus. The contacts of the two additional cases confirmed today (February 6) are being traced. The total number of the contacts of the other 10 confirmed cases is 493. Of 493, 12 contacts developed symptoms and were reported. Of 12 reported cases, 2019-nCoV has been ruled out in 10, and 2 are being tested. With respect to the Taiwanese businesspeople returning to Taiwan from Wuhan in the evening on February 3, as of now, five individuals are being treated in negative pressure isolation wards while 242 are under group quarantine and their health conditions are being monitored. The other five displayed symptoms, and two of five will be sent to the hospital for tests.

1. CECC was notified by Japan’s health authorities earlier on February 6 that a Taiwanese passenger on the cruise ship, the Diamond Princess, has been diagnosed with 2019 Novel Coronavirus (2019-nCoV).
2. The passenger has been hospitalized in the designated hospital in Japan to receive medical treatment in an isolation ward. The health authority has requested that other Taiwanese passengers remain in the cabin and at least under quarantine on board for 14 days.
3. Japan’s health authorities indicated that they will notify Taiwan’s competent authorities if more test results come out.

CECC pointed out that several community-transmitted cases with unknown origin have occurred in Hong Kong, indicating the possibility of invisible chain of infection. On the other hand, a worker in the gambling industry of Macau has been diagnosed with 2019-nCoV infection, indicating a second wave of infection in Macau. Due to the close social and commercial exchanges between Macau and China, the travel notice level for Hong Kong and Macau was raised to Level 2: Alert on February 5. CECC urges travelers visiting the areas to reinforce prevention measures. Furthermore, CECC will closely monitor the development of disease outbreak and adjust endemic area and the level of travel notices accordingly. 

The Central Epidemic Command Center (CECC) has made a protest against the WHO report and requested WHO to revise the number of confirmed cases in Taiwan, from 13 to 10, and correct our country name through the National IHR Focal Point (NFP).

Among these evacuees, three individuals were sent to negative pressure isolation wards directly. Of three cases, 2 individuals developed respiratory symptoms and one had a fever. Additionally, one child had abdominal pain (who was accompanied by a parent) and was determined to be in no need of hospitalization in a negative pressure ward. The child was then sent to one of the three designated quarantine sites with other asymptomatic evacuees. All these evacuees arrived at the quarantine sites and settled in at 6:20 am.

All evacuees will be placed under quarantine and will not be allowed to leave their rooms. Therefore, they will not have any contact with nearby residents. The public is advised to remain calm. 

CECC pointed out highlights of the change in the sale of face masks:
1.    Convenience stores will stop selling the face masks requisitioned by the government to fulfill livelihood needs starting from February 4.
2.    The National Health Insurance Administration (NHI) will make some changes to national computer database and complete related tests in two days. Face masks will be distributed to 6,505 NHI contracted pharmacies or drugstores through postal services. Each drugstore or pharmacy will give out 200 adult face masks and 50 face masks for children whereas local district public health centers will perform the distribution in rural areas. The public can bring their (NHI) IC cards to purchase face masks starting from February 6. Each person is allowed to buy two masks per IC card at a price of NT$10 in a week.
3.    To reduce the queue for face masks, the policy allows the people whose ID card number ends with an even number to buy masks on Tuesdays, Thursdays and Saturdays, and the people whose ID card number ends with an odd number to buy masks on Mondays, Wednesdays and Fridays while everyone can buy them on Sundays. Furthermore, office workers and people with disabilities can ask their family members or friends to buy face masks on their behalf. However, each person is allowed to buy face masks for another person by presenting the person’s IC card, and the abovementioned rules of purchase apply. Moreover, face masks for children are only allowed to be purchased when IC cards of children under 12 are presented.
4.    Regarding the elderly living alone and physically or mentally challenged people in need of face masks, local social welfare bureaus and public health bureaus will cooperate to provide face masks from the local government’s stockpile of face masks in order to prioritize them for these minority groups.

CECC emphasized that domestic experts have reiterated three appropriate situations where people should put on face masks: when visiting hospitals, accompanying patients and visiting patients; when people are sick with symptoms of respiratory infections; and when people with chronic diseases go outside. The healthy public and students don’t need to wear face masks. It is advised that face masks shall be prioritized for the people in great need of masks in order to maximize the efficacy of resources. 

CECC also announced that travelers with a history of travel to Wenzhou City are subject to home quarantine when they enter Taiwan and that Wenzhou residents are prohibited from entering Taiwan. If fever or respiratory illness symptoms develop when travelers enter Taiwan, such travelers will be transferred to the designated healthcare facilities for sample collection and sent back home for quarantine. If such travelers test positive, they will be subject to compulsory quarantine according to the procedure of handling confirmed cases. 

CECC also announced today (February 3) that 61 additional cases of 2019 Novel Coronavirus (2019-nCoV) infection were reported in Taiwan on February 2. As of writing, a cumulative total of 1,066 cases have been reported, including 10 confirmed cases, 900 individuals removed from the follow-up list, and the remaining ones under quarantine for lab tests of who preliminary tests were negative in 85 and the others are awaiting tests. 10 confirmed cases are currently in a stable condition and being treated in isolation in the hospital. The hospital and local health agencies have proceeded with prevention measures, including the investigation of the cases and contact tracing, according to relevant procedures. The total number of contacts of 10 confirmed cases is 515. Of 515, 35 contacts developed symptoms and were reported. Of 35 reported cases, 2019-nCoV infection has been ruled out in 32, and the other 3 are being tested.

According to the statistics collected by CECC, 89 additional cases of 2019-nCoV infection were reported in Taiwan on February 1, 2020. As of writing, a cumulative total of 1007 cases have been reported, including 10 confirmed cases, 829 individuals removed from the follow-up list, and the remaining ones under quarantine for lab tests of who preliminary tests were negative in 91 and the others are awaiting tests. The hospital and local health agencies have proceeded with prevention measures, including the investigation of the cases and contact tracing, according to relevant procedures. The total number of contacts of 10 confirmed cases is 486. Of 486, 34 contacts developed symptoms and were reported. Of 34 reported cases, 32 tested negative for 2019-nCoV infection, and the other 2 are being tested.

The program invites experts from industry, academia and government as lecturers to share their valuable experience in the field. In order to provide quality curriculum design, it will focus on courses with high ratings from previous class satisfaction surveys. This will support the need for appropriately qualified investigators to conduct clinical trials at all stages. Those participated in the entire course and passing the assessment will be able to download course certificates on the platform. In addition, it provides continuing education credits for health professionals such as physicians, nurses and pharmacists, and lifelong learning points for government employees.

To enhance the quality of clinical trials, the TFDA has promoted the training courses for clinical trials and the concept of protecting the rights of subjects. These courses focus on the theoretical basis of clinical research and the practical aspects of conducting clinical trials such as the principles of early trial design features, recruitment of participants, data collection, etc. There will be other important courses coming one after another. The program is delivered online, allowing for a curriculum design that caters to different ways of learning. As the online platform is more convenient, anyone interested is encouraged to participate and provide feedback.

According to the statistics collected by CECC, 109 additional cases of 2019-nCoV infection were reported in Taiwan on January 29. As of writing, a cumulative total of 730 cases have been reported, including nine confirmed cases, 482 individuals removed from the follow-up list, and 239 under quarantine for lab tests of who preliminary tests were negative in 98 and tests of the others are pending. Nine confirmed cases are in a stable condition and being treated in isolation in the hospital. The hospital and local health agencies have proceeded with prevention measures, including the investigation of the cases and contact tracing, according to relevant procedures. The total number of contacts of the other eight confirmed cases is 486. Of 486, 29 contacts developed symptoms and were reported. Of 29 reported cases, 17 tested negative for 2019-nCoV infection after the second test, and 12 are awaiting tests. In 7 of the 12 contacts, a second confirmatory test was conducted while the test results of the other 5 contacts are pending.

CECC indicated that in order to reach a rational distribution of face masks in Taiwan, CECC will requisition medical face masks and surgical masks produced by domestic mask manufacturers starting from January 31, approximately 4 million masks every day. These masks will be distributed by CECC to fulfill the needs of livelihood (about 2.6 million masks will be released every day) and of medical treatment or prevention efforts as well as storage (about 1.4 million masks will be released every day) by the government. The masks for the needs of livelihood will be provided in channels, such as convenience stores, beauty stores, drug stores and medical supply stores. With respect to the masks to be released, each person will only be allowed to buy no more than three masks at a time. The policy is set to remain effective until February 15. CECC urged that the healthy public does not need to wear a face mask to allow masks to be purchased by people who have chronic diseases, who need medical attention, who accompany a patient for doctor appointments and the visitor of a patient. CECC reminded that people with respiratory symptoms should wear a face mask; patients with chronic diseases are advised to wear a face mask when going outside; and people in a crowded place without good ventilation are advised to wear a face mask.

The Central Epidemic Command Center (CECC) pointed out that as the number of cases of 2019 novel coronavirus (2019-nCoV) infection in China continues to grow, CECC issued relevant guidance for public transportation, public gatherings, schools and educational institutions and groups and provided advice on prevention measures to reduce the risk of infection. Such information is available under the section of 2019-nCoV (Wuhan pneumonia) on the Chinese version of the website of Taiwan Centers for Disease Control (Taiwan CDC) at https://www.cdc.gov.tw/Category/MPage/V6Xe4EItDW3NdGTgC5PtKA (provided in Chinese only).

According to the statistics collected by CECC, 96 additional cases of 2019-nCoV infection were reported in Taiwan on January 28. As of writing, a cumulative total of 621 cases have been reported, including eight confirmed cases, 386 individuals removed from the follow-up list, and 277 under quarantine for lab tests. Of 277, preliminary tests were negative in 92 and the others are to be tested. Eight confirmed cases are in a stable condition and being treated in isolation at the hospital. The hospital and local health agencies have proceeded with prevention measures, including the investigation of the cases and contact tracing, according to relevant procedures. The total number of contacts of the eight confirmed cases is 460. Of 460, 27 contacts developed symptoms and were reported, and confirmed case #8 who is a contact of confirmed case #5 has been determined as a confirmed case.  Of 27 reported cases, 12 tested negative for 2019-nCoV infection after the second test, and 5 tested negative after the preliminary test while the test results of the other 10 cases are pending.

According to the statistics collected by CECC, 130 additional cases of 2019-nCoV infection were reported in Taiwan on January 27. As of writing, a cumulative total of 530 cases have been reported, including seven confirmed cases, 269 individuals removed from the follow-up list, and the remaining ones under quarantine for lab tests of who preliminary tests were negative in 98 and tests of the others are pending. Seven confirmed cases are in a stable condition and being treated in isolation at the hospital. The contacts of confirmed case #6 and #7 are being traced. On the other hand, the total number of contacts of the other five confirmed cases is 470. Of 470, 16 contacts developed symptoms and were reported. In 10 of the 16 contacts, 2019-nCoV has been ruled out after the second test, while the other 6 are being tested.

According to the reporting data provided by the Chinese Center for Disease Control and Prevention and data published by the local health commission in each Chinese province and city, as of January 27 a cumulative total of 4,515 confirmed cases of 2019-nCoV infection have been recorded in China, including 976 severe cases and 106 deaths. Of 31 Chinese provinces and cities (excluding Hong Kong and Macau), Tibet is the only region where no confirmed or suspected case has occurred. More cases continue to occur in Chinese provinces and cities, indicating a serious outbreak. Furthermore, the World Health Organization (WHO) has announced that the novel coronavirus could sustain human-to-human transmission, indicating higher risk of infection. Thus, CECC broadened the region of travel notice of Level 3 to China (excluding Hong Kong and Macau) on January 28. The public is advised to avoid non-essential travels to China. 

According to the statistics collected by CECC, 52 additional cases of 2019-nCoV infection were reported in Taiwan as of 4 pm on January 28, 2020. As of writing, a cumulative total of 578 cases of 2019-nCoV infection have been reported. Test results showed that infection with 2019-nCoV was confirmed in eight cases; 321 individuals were removed from the follow-up list; preliminary tests were negative in 75; the remaining ones are to be tested. Additionally, 9 cases which had been reported for unexplained pneumonia have been removed from the followed-up list.

CECC urges people to cooperate and abide by prevention measures implemented if they receive notice of of being identified as contacts from health units. Such measures include avoiding public places, wearing a face mask when going out, conducting hand and respiratory health, taking the temperature and keeping an activity log during the 14-day health monitoring period, wearing a surgical mask and voluntarily contact local health bureaus immediately if fever or respiratory symptoms develop, and voluntarily informing the physician of any history of travel, occupation, contact, and cluster. CECC will enforce the measures and place violators in isolation for quarantine and request the Ministry of Justice and National Police Agency to handle the matter.

According to the reporting data provided by the Chinese Center for Disease Control and Prevention and data published by local health commission in each Chinese province and city, as of January 25 a cumulative total of 1,975 confirmed cases of 2019-nCoV infection have been recorded in China, including 324 severe cases and 56 deaths cumulatively. Of 31 Chinese provinces and cities (excluding Hong Kong and Macau), Tibet is the only region where no confirmed or suspected case has occurred. A cumulative total of 36 confirmed cases have been recorded in other countries, excluding Taiwan. 36 confirmed cases include 5 cases in Thailand, 5 in Hong Kong, 4 in Australia, 4 in Malaysia, 3 in Japan, 3 in Singapore, 3 in France, 2 in Macau, 2 in Vietnam,2 in South Korea, 2 in the United States, and 1 in Nepal.

CECC broadened the travel notice for Wuhan and changed to Hubei Province and raised the level for Hubei Province to Level 3: Warning on January 25. The public is advised to avoid non-essential trips to the area. CECC also raised travel notice level for other Chinese provinces to Level 2: Alert; travelers visiting China are advised to reinforce prevention measures. CECC urges the public to take the temperature, wash hands thoroughly with soap, refrain from touching eyes, nose and mouth with hands and avoid crowded public places. If symptoms such as fever, cough and shortness of breath develop, please rest at home and stay clear of public places. If going out is necessary, please put on a surgical mask, wash hands thoroughly with soap and appropriately dispose of respiratory secretions.

Travelers arriving in Taiwan are advised to voluntarily inform the quarantine officer at the airport/port if symptoms such as fever and cough develop. If the aforementioned suspected symptoms develop within 14 days after returning to Taiwan, please call the toll-free Communicable Disease Reporting and Consultation Hotline, 1922 (or 0800-001922) and put on a surgical mask and seek immediate medical attention as instructed. Moreover, please inform the physician of any history of travel, occupation, contact, and cluster (TOCC) to facilitate timely diagnosis and prompt case-reporting. For more information on 2019-nCoV, please visit the Taiwan CDC website at http://www.cdc.gov.tw.

According to the statistics collected by CECC, as of 4 pm on January 26, 67 new cases of 2019-nCoV infection have been reported. As of writing, a cumulative total of 350 cases have been reported, including four confirmed cases, 147 individuals removed from the follow-up list; preliminary tests were negative in 41 and test results of others are pending.

For more questions, please call the toll-free Communicable Disease Reporting and Consultation Hotline, 1922 (or 0800-001922). 

60 more cases of 2019 novel coronavirus (2019-nCoV) infection were reported on January 24. As of writing, a total of 193 cases of 2019-nCoV infection have been reported, including three confirmed cases, 64 individuals removed from the follow-up list, and 126 in isolation for lab tests among which preliminary tests were negative in 46 and test results of the others are pending. The three confirmed cases are currently being treated in a negative pressure ward at the hospital. Of 46 contacts of the first confirmed cases, one individual developed fever and was hospitalized. In the other two confirmed cases, the number of close contacts identified is currently 102 and other contacts are being traced and under investigation while others remain in normal condition. The Taiwan Centers for Disease Control (Taiwan CDC) informs that as Case-patient #2 announced on January 24 was present at Jin Bali Grand Ballroom located in Lingya District, Kaohsiung City from 4 to 6 pm on January 22 without a face mask throughout his visit, if any individuals visited the ballroom during the aforementioned period of time, he/she is advised to conduct self-health management for 14 days since the last contact date. If symptoms such as fever, cough and shortness of breath develop, please call the toll-free Communicable Disease Reporting and Consultation Hotline, 1922 (or 0800-001922) and put on a surgical mask and seek immediate medical attention as instructed. Moreover, please inform the physician of any history of contact to reduce the risk of virus transmission.

According to the reporting data provided by the Chinese Center for Disease Control and Prevention, as of January 24 a cumulative total of 1,287 confirmed cases of 2019-nCoV infection have been recorded in China, including 237 severe cases and 41 deaths cumulatively. Of 31 Chinese provinces and cities (excluding Hong Kong and Macau), confirmed or suspected cases have been reported in 30 provinces and cities. The cumulative number of close contacts is 15,197, and the number of individuals being tracing is 13,967. As of now, Tibet is the only region where no confirmed or suspected case has occurred. More cases continue to occur in Chinese provinces and cities with cases in the cities in Hubei Province besides Wuhan increasing rapidly, and the World Health Organization (WHO) has announced that the novel coronavirus can sustain human-to-human transmission, indicating higher risk of infection. Thus, CECC broadened the travel notice to Hubei Province (including Wuhan City) and raised the level for Hubei Province to Level 3: Warning on January 25. The public is advised to avoid non-essential trips to the area. CECC also raised travel notice level for other Chinese provinces to Level 2: Alert; travelers planning to visit China are advised to reinforce prevention measures. A cumulative total of 31 confirmed cases have been recorded in 12 other countries. New cases have been recorded in Malaysia, Australia, Nepal and France in addition to global cases as disclosed in the press release dated January 23. 31 cases include 5 cases in Thailand, 5 in Hong Kong, 3 in Singapore, 3 in Malaysia, 3 in France, 2 in Japan, 2 in Korea, 2 in Macau, 2 in Vietnam, 2 in the United States, 1 in Nepal and 1 case in Australia.

CECC reiterates that upon receipt of report of communicable diseases, competent authorities will proceed with the investigation of the outbreak and investigate and handle each potential contact pursuant to Article 43, the Communicable Disease Control Act. Whether details about the process of a reported case are made public or not depends on the transmission means as well as characteristics of the disease. Disclosure of such details will only be made to facilitate the investigation of disease outbreak. Revealing unnecessary information for the investigation might cause public panic and thus not help implement prevention measures. As the period of time calls for alertness to comprehensive prevention, CECC takes disclosure of such information seriously, handles it with prudence and has no intention of concealment. CECC urges the public and the press to understand its intent and cooperate with the measures.

CECC reminds that the outbreak of this novel coronavirus in China is occurring during the Lunar New Year holiday and urges the healthy public to take the temperature, wash hands thoroughly with soap, refrain from touching eyes, nose and mouth with hands and avoid going to crowded public places. If symptoms such as fever, cough and shortness of breath develop, please rest at home and stay clear of public places. If going to a doctor or attending important business is necessary, please put on a surgical mask, wash hands thoroughly with soap and appropriately dispose of respiratory secretions.

Travelers arriving in Taiwan are advised to voluntarily inform the quarantine officer at the airport/port if symptoms such as fever and cough develop. If the aforementioned suspected symptoms develop within 14 days after returning to Taiwan, please call the toll-free Communicable Disease Reporting and Consultation Hotline, 1922 (or 0800-001922) and put on a surgical mask and seek immediate medical attention as instructed. Moreover, please inform the physician of any history of travel, occupation, contact, and cluster (TOCC) to facilitate timely diagnosis and prompt case-reporting. For more information on 2019-nCoV, please visit the Taiwan CDC website at http://www.cdc.gov.tw.

In light of the pneumonia outbreak in Wuhan, Taiwan’s China Airlines, Mandarin Airlines, Air China and China Southern Airlines suspended all direct flights (12 flights a week) to and from Wuhan starting from January 23. As of January 22, a total of 38 flights and 4,625 passengers and cabin crews have been inspected without new additional case of hospitalization. 70 new cases were reported on January 22. As of writing, a total of 134 cases of the novel virus have been reported, including one confirmed cases announced on January 21, 27 individuals removed from the follow-up list and 106 individuals in isolation for lab tests, among which 21 were first tested negative for 2019-nCoV while test results of the others are pending. On the other hand, the confirmed case-patient is currently being treated in a negative pressure ward at the hospital. Of 46 contacts of the confirmed case, one individual with a mild cough without fever as indicated in the news story dated January 22 have recovered whereas one individual developed fever on January 23 and the other individuals have not developed any symptoms. 

According to the reporting data provided by the Chinese Center for Disease Control and Prevention as of January 23, of 31 Chinese provinces and cities (excluding Hong Kong and Macau), confirmed cases have been reported in 29 provinces and cities with a cumulative total of 830 confirmed cases, including 177 severe cases and 25 deaths cumulatively. The number of close contacts is 9,507, and the number of individuals being tracing is 8,420. A total of 16 confirmed cases have been recorded in other countries and areas, including 4 cases in Thailand, 2 in Hong Kong, 2 in Macau, 2 in Vietnam, 2 in Japan, 1 in Taiwan, 1 in Singapore, 1 in South Korea and 1 case in the United States.

CECC pointed out that the public does not need to specifically visit the eight hospitals designated to inspect and test 2019-nCoV infection. As long as the physician determines that an individual meets the criteria for case reporting when he/she goes to a healthcare facility, his/her samples will be delivered to the Taiwan Centers for Disease Control (Taiwan CDC) or the eight designated hospitals for testing. If the aforementioned symptoms develop within 14 days after returning to Taiwan, please call the toll-free Communicable Disease Reporting and Consultation Hotline, 1922 (or 0800-001922) and put on a surgical mask and seek immediate medical attention as instructed. Moreover, please inform the physician of any history of travel, occupation, contact, and cluster (TOCC) to facilitate timely diagnosis and prompt case-reporting. For more information on 2019-nCoV, please visit the Taiwan CDC website at http://www.cdc.gov.tw.

As of 4 pm on January 24, 35 new cases of 2019-nCoV infection have been reported in Taiwan.  As of writing, a total of 168 cases have been reported, including three confirmed cases (one of which was announced on January 21), 42 individuals removed from the follow-up list, and 23 first tested negative for 2019-nCoV, and test results of the others are pending.

CECC keeps integrating resources across government agencies and reinforcing quarantine measures at international (including cross-strait) airports/ports as well as risk communication with the public and public awareness about the disease, ensuring the preparation of pharmaceutical and medical supplies to prevent the occurrence of fake news concerning shortages and price gouging and reduce public panic, and planning and conducting drills for nosocomial infection control at healthcare facilities to minimize the impact of the outbreak on Taiwan. Such efforts aim to safeguard domestic prevention work and protect health of Taiwanese public. 

CECC recommends the healthy public to take the temperature and wash hands thoroughly with soap, avoid touching eyes, nose and mouth with hands and avoid going to crowded public places. If symptoms such as fever, cough and shortness of breath develop, please rest at home and stay clear of public places. If going to a doctor or attending important business is necessary, please put on a surgical mask, wash hands thoroughly with soap and appropriately dispose of respiratory secretions

Traveler visiting China recently are advised to wash hands thoroughly with soap, wear a surgical mask when coughing, avoid contact with wild animals and patients with acute respiratory tract infections and avoid visiting traditional markets and healthcare facilities throughout the trip. If symptoms such as fever or cough develop upon arriving in Taiwan, please voluntarily notify the quarantine officer at the airport/port. If the aforementioned symptoms develop within 14 days after returning to Taiwan, please call the toll-free Communicable Disease Reporting and Consultation Hotline, 1922 (or 0800-001922) and put on a surgical mask and seek immediate medical attention as instructed. Moreover, please inform the physician of any history of travel, occupation, contact, and cluster (TOCC) to facilitate timely diagnosis and prompt case-reporting. For more information on 2019-nCoV, please visit the Taiwan CDC website at http://www.cdc.gov.tw.

Public transport in Wuhan City has been temporarily suspended due to the epidemic outbreak, and Taiwanese businesspeople might not be able to leave Wuhan. The Border Affairs Corps, Ministry of National Immigration Agency has been informed to examine the entry permit of mainland Chinese and decline entry of people who resides or originally resided in Wuhan. Moreover, all airline companies have been informed that ground crew must check the residence or place of birth on the entry permit when checking the permit at departing airports; if the aforementioned column is left blank, the traveler will be asked to present his/her Resident Identity Card; such traveler will be declined to board the plane to Taiwan if his/her residence is Wuhan City, Hubei Province. The responsible authority will trace Taiwanese businesspeople who have not managed to leave Wuhan using their registered information established by the Mainland Affairs Council (MAC) and actively express concerns to these Taiwanese people about their health and further understand the real situation in Wuhan.

According to the reporting data provided by the Chinese Center for Disease Control and Prevention, among 31 Chinese provinces and cities (excluding Hong Kong and Macau), confirmed cases of the Wuhan pneumonia have been reported in 24 provinces and cities  with a cumulative total of 571 confirmed cases, including 95 severe cases and 17 deaths cumulatively. Of eight deaths recorded on January 22, one case was 53 years old while 7 other cases were over 65 years old and had chronic diseases and conditions such as post cancer, hepatic insufficiency, hypertension and diabetes and these deaths was recorded in Hubei Province. The number of close contact is 5,897, and the number of individuals being traced is 4,928. A total of 11 confirmed cases have been recorded in other countries and areas, including 4 cases in Thailand, 2 in Hong Kong, 1 in Taiwan, 1 in Japan, 1 in South Korea, 1 in the United States and 1 case in Macau.

In light of the pneumonia outbreak in Wuhan, CECC continues bolstering outbreak surveillance and border quarantine measures and inquiring travelers with fever arriving in Taiwan through international (including cross-strait) and ports about history of travel to Wuhan and conducting their health assessment. Onboard quarantine of all direct flights arriving from Wuhan has been implemented since December 31, 2019. Thus far, a total of 38 flights and 4,625 passengers and cabin crews have been inspected without new additional case of hospitalization. 45 new cases were reported on January 22. As of writing, a total of 65 cases of 2019-nCoV infection have been reported, including one confirmed cases announced on January 21, 10 individuals removed from the follow-up list, 54 individuals in isolation for lab tests. On the other hand, the confirmed case-patient is currently being treated in a negative pressure ward at the hospital, and 46 individuals who had contact with the case did not develop any symptoms except for one individual with a mild cough without fever. 

CECC reminds the public again that the travel notice level for Wuhan has been raised to Level 3: Warning and that the local public transport has been shut down and urges the public to avoid all non-essential travels to Wuhan. Travelers visiting Wuhan are advised to wash hands thoroughly with soap, wear a surgical mask and seek medical attention when coughing, avoid contact with wild animals and patients with acute respiratory tract infections and avoid visiting traditional markets and healthcare facilities throughout the trip. If symptoms such as fever or cough develop upon arriving in Taiwan from Wuhan or other neighboring areas in China, whether or not cough or fever medicines have been taken, please voluntarily notify the quarantine officer at the airport/port to receive health assessment. If the aforementioned symptoms develop within 14 days after returning to Taiwan, please call the toll-free Communicable Disease Reporting and Consultation Hotline, 1922 (or 0800-001922) and put on a surgical mask and seek immediate medical attention as instructed. Moreover, please inform the physician of any history of travel, occupation, contact, and cluster (TOCC) to facilitate timely diagnosis and prompt case-reporting. For more information on 2019-nCoV, please visit the Taiwan CDC website at http://www.cdc.gov.tw.

In the afternoon of January 20, the Executive Yuan Vice Premier Chen Chi-mai (陳其邁) attended the command center meeting and was briefed. Vice Premier Chen instructed that all government agencies must rapidly and fully support the Ministry of Health and Welfare (MOHW) in all disease prevention and control efforts to demonstrate the capacity and the resolve to effectively tackle the threats and challenges posed by the outbreak to the public. Such efforts include thorough implementation of quarantine measures at international and three-small-link airports and ports, reinforcing risk communication with the public and public awareness about the disease, ensuring the preparation of pharmaceutical and medical supplies to prevent the occurrence of fake news concerning shortages and price gouging and reduce public panic, and planning and conducting drills for nosocomial infection control at healthcare facilities to minimize the impact of the outbreak on Taiwan.

During the expert consultation meeting, the participating experts recommended to expand the target population for the reporting criteria of cases of severe special infectious pneumonia and include all pneumonia cases with history of travel to China rather than history of travel to Wuhan, China in order to broaden the scope of surveillance and promptly identify suspected cases. On the other hand, the experts also recommended distributing health education pamphlets— “Travel-related Outbreak Warning: Voluntary Health Assessment” on all arriving flights from China, Hong Kong and Macau. In addition, the experts also asked Taiwan CDC to confirm the diagnostic capacity and assist healthcare facilities in making an inventory of the isolation wards in response to the demand caused by increased travel during the Chinese New Year holiday.

Taiwan CDC reminds travelers planning to visit Wuhan or other neighboring areas in China recently to wash hands thoroughly with soap, wear a surgical mask and seek medical attention when coughing, avoid contact with wild animals and patients with acute respiratory tract infections throughout the trip. If symptoms such as fever or cough develop upon arriving in Taiwan, please voluntarily notify the quarantine officer at the quarantine station in the airport/port. If the aforementioned symptoms develop within 14 days after returning to Taiwan, please put on a surgical mask and seek immediate medical attention. Moreover, please inform the physician of any history of travel, occupation, contact, and cluster (TOCC) to facilitate timely diagnosis and prompt case-reporting. For more information on severe special infectious pneumonia, please visit the Taiwan CDC website at http://www.cdc.gov.tw or call the toll-free Communicable Disease Reporting and Consultation Hotline, 1922 (or 0800-001922).

CECC indicated that a total of 440 cases of 2019-nCoV infection have been confirmed in China according to the reporting data provided by the Chinese Center for Disease Control and Prevention, including 9 deaths. These cases include 258 patients in Wuhan City, 12 in Huanggang City, 17 in Guangdong Province, 6 in Shanghai City, 10 in Beijing City, 5 in Zhejiang Province and Chongqing City respectively, 2 in Tianjin City, Sichuan Province and Jiangxi Province respectively and 1 in Henan Province, Yunnan Province, Shandong Province and Hunan Province respectively while the location of remaining cases has not been disclosed.  As of writing, a total of 9 cases with history of travel to Wuhan have been reported in other countries and areas, including 4 cases in Thailand and 1 case in Taiwan, Japan, South Korea, the United States and Macau respectively.

In light of the pneumonia outbreak in Wuhan, CECC continues bolstering outbreak surveillance and border quarantine measures and inquiring travelers arriving in Taiwanwith fever through international (including cross-strait) airports and ports about history of travel to Wuhan and conducting their health assessment.  Onboard quarantine of all direct flights arriving from Wuhan has been implemented since December 31, 2019. Thus far, a total of 37 flights and 4,469 passengers and cabin crews have been inspected without new additional case of hospitalization. 9 cases of 2019-nCoV infection reported before the epidemic was categorized as communicable disease in law have been removed from the follow-up list. As of now, a total of 21 suspected cases have been reported after the statutory categorization of 2019-nCoV, including 8 individuals removed from the follow-up list, 12 individuals in isolation for lab tests, and 1 confirmed cases announced as the first imported case on January 21. The patient is now receiving treatment in a negative pressure ward at the hospital and 46 individuals who had contact with the case did not develop any symptoms except for 1 with a mild cough without fever.

CECC urges the public that the travel notice level for Wuhan has been raised to Level 3: Warning, recommending the public to avoid all non-essential travels to Wuhan. Travelers visiting Wuhan are advised to wash hands thoroughly with soap, wear a surgical mask and seek medical attention when coughing, avoid contact with wild animals and patients with acute respiratory infections and avoid visiting traditional markets and healthcare facilities throughout the trip. If symptoms such as fever or cough develop upon arriving in Taiwan from Wuhan or other neighboring areas in China, whether or not cough or fever medicines have been taken, please voluntarily notify the quarantine officer at the airport/port to receive health assessment. If the aforementioned symptoms develop within 14 days after returning to Taiwan, please call the toll-free Communicable Disease Reporting and Consultation Hotline, 1922 (or 0800-001922) and put on a surgical mask and seek immediate medical attention as instructed. Moreover, please inform the physician of any history of travel, occupation, contact, and cluster (TOCC) to facilitate timely diagnosis and prompt case-reporting. For more information on 2019-nCoV, please visit the Taiwan CDC website at http://www.cdc.gov.tw.

CECC pointed out that the hospital and the corresponding local health authority have both followed the standard operation procedures to report the case, collect specimens from the case, treat the case in isolation, conduct epidemiological investigation, and follow up the 46 contacts on the same flight. The isolation will only be lifted after the patient is symptom-free and tested negative for 2019-nCoV twice. Concerning Taiwan’s first confirmed case, CECC has simultaneously notified the World Health Organization (WHO) through the National IHR Foal Point.

As the number of cases in Wuhan is increasing rapidly, a leading infectious disease expert in china have strongly advised travelers against visiting Wuhan. On January 21, WHO furthen pointed out that the 2019-nCoV might have sustained human-to-human transmission. As the first imported case from Wuhan has been confirmed in Taiwan, CECC announced raising the travel notice level for Wuhan to Level 3: Warning, reminding the public to avoid all non-essential travels to Wuhan.

As the pneumonia outbreak caused by 2019-nCoV in China has obviously resulted in community transmission and spread, CECC will continue to integrate resources across government agencies, reinforce implementation of quarantine measures at international including cross-strait airports and ports, reinforce risk communication with the public and public awareness about the disease, ensure the preparation of pharmaceutical and medical supplies to prevent the occurrence of fake news concerning mask shortages and price gouging and reduce public panic, and plan and conduct drills for hospital infection control at healthcare facilities in order to minimize the impact of the outbreak on Taiwan, tackle the threats and challenges posed by the outbreak, and ensure the health of the Taiwanese public.

Taiwan CDC recommeds travelers visiting Wuhan or other neighboring areas in China wash hands thoroughly with soap, wear a face mask and seek medical attention when coughing, avoid contact with wild animals and patients with acute respiratory infections, and avoid visiting traditional markets and healthcare facilities throughout the trip. If symptoms such as fever or cough develop upon arriving in Taiwan, please voluntarily notify the quarantine officer at the airport/port. If the aforementioned symptoms develop within 14 days after returning to Taiwan, please put on a surgical mask and seek immediate medical attention. Moreover, please inform the physician of any history of travel, occupation, contact, and cluster (TOCC) to facilitate timely diagnosis and prompt case-reporting. For more information on 2019-nCoV, please visit the Taiwan CDC website at http://www.cdc.gov.tw or call the toll-free Communicable Disease Reporting and Consultation Hotline, 1922 (or 0800-001922).

On January 15, 2020, Taiwan CDC was notified by the Chinese Center for Disease Control and Prevention that the total number of cases of the novel coronavirus-associated pneumonia remained at 41, including 6 severe cases, 1 deaths, and 7 cases that had been discharged from the hospital. On the other hand, on January 16, 2020, Japan announced the first imported case of the Wuhan novel coronavirus. The case developed fever during his stay in Wuhan, but he did not visit the Huanan Seafood Market, which is linked to most cases. Nevertheless, it was possible that he came into close contact with patients of unexplained pneumonia. Taiwan CDC will continuously closely monitor the development of the case. Since confirmed cases that had not visited the Huanan Seafood Market have been subsequently reported in Thailand and Japan, limited human-to-human spread in Wuhan cannot be ruled out. Additionally, as the source of infection is still under investigation, Taiwan CDC has raised the travel notice level for Wuhan City to Level 2: Alert, advising travelers planning to recently visit Wuhan and other neighboring areas in China to take personal precautions to ward off infection.

Taiwan CDC has increased vigilance for suspected cases at international and three-small-link airports and ports, inquiring all arrival passengers with fever of their history of travel, occupation, contact, and cluster (TOCC) and evaluating their health. All travelers who have visited Wuhan, China and developed symptoms such as fever or coughing are urged to voluntarily notify the quarantine officers at the airport of their symptoms regardless of whether they are on any medications in order to assist the unwell passengers in seeking appropriate medical attention and assessing their health. Since December 31, 2019, Taiwan CDC has been implementing onboard quarantine of all direct flights arriving from Wuhan. Thus far, a total of 26 flights and 2,845 passengers and cabin crews have been inspected. A total of 13 individuals have displayed symptoms. Among them, 7 individuals have been removed from the follow-up list. As the other 6 individuals have had improvement in symptoms or recovered, hospital visit has been deemed unnecessary for them. Nonetheless, they will be continuously followed up by the local health bureau. As of now, 9 individuals who have met the reporting criteria of “a pneumonia case with fever and travel history to Wuhan, China” have all been tested negative for the 2019 novel coronavirus (2019-nCoV). In other words, there is currently no confirmed case of the 2019 novel coronavirus in Taiwan.

Taiwan CDC advises travelers planning to visit Wuhan or other neighboring areas in China to avoid visiting live poultry markets and avoid contact with wild animals and poultry, and take appropriate personal precautions to ward off infection. If the suspected symptoms develop within 14 days after returning to Taiwan, please put on a surgical mask and seek immediate medical attention. Moreover, please inform the physician of any history of travel, occupation, contact, and cluster (TOCC) to facilitate timely diagnosis, prompt case-reporting, and comprehensive treatment. For more information, please visit the Taiwan CDC website at http://www.cdc.gov.tw or call the toll-free Communicable Disease Reporting and Consultation Hotline, 1922 (or 0800-001922).

The uses of food ingredients and additives, sanitation standards and labeling requirements for infant formula and follow-up infant formula, shall comply with the relevant provisions of the Act. All registration applications are thoroughly reviewed on a case by case basis to ensure the formula product meeting compositional, quality, and safety requirements. Related documents and information including bill of materials, nutrient analysis and specification, the evidences for product sales outside Taiwan, package labeling in Chinese, etc. are required for product registration. The Act and related regulations are available on the TFDA website (http://www.fda.gov.tw/ENG/law.aspx?cid=16). Registration regulation can be found at the following link: http://www.fda.gov.tw/ENG/lawContent.aspx?cid=16&id=3124.

The AHWP, an international platform for medical device regulation harmonization for both side of the stakeholders, the regulators and industry, can come together to make out the differences as well as grooming the upcoming regulatory professionals to better serve the sector. AHWP was established in 1999 as a voluntary group of regulators and industry members whose goal is working towards greater harmonization of medical device regulations in Asia, and Taiwan has been an official member since then.

Taiwan was elected as AHWP Vice-chair in 2012 with mission aiming in developing AHWP strategy, and its expansion with international focus. In the same year, Taiwan was also elected as the Chair of In Vitro Diagnostic (IVD) working group (WG2), and continued in office for other two three-years terms until now. WG2 being the most active working group in the AHWP Technical Committee, has been focusing on the harmonization of IVD medical device regulation. In the period of Taiwan chairing the WG2, it has developed fourteen IVD guidance or reference documents and endorsed by the AHWP to support its goal. Furthermore, Taiwan has been active in leading WG2 to collaborate with other AHWP working groups, in addition to collaborating with WHO IVD pre-qualification team to contribute technical comments to WHO Technical Specification and Technical Guidance documents.

With the continuous participation of TFDA and Taiwan in AHWP, sharing the Taiwan experience with the global regulatory professionals, it has shown the Taiwan’s medical device regulatory leadership in Asia and beyond.

Medical strengths attracts people overseas

Taiwan's excellent medical technology has set many records in cardiovascular care. For example, the atrial fibrillation ablation surgery in Taipei Veterans General Hospital is unique to the world. The American Heart Rhythm Society honored this as “Taipei Approach”. National Taiwan University Hospital’s ECMO team is a pioneer in the field of ECMO-assisted resuscitation. They have great achievement in both clinical and academic aspects. The minimally invasive surgical technique was blooming in the past few years. Among them, minimally invasive cardiac surgery in Far Eastern Memorial Hospital has become the benchmark. This sophisticated technique has the advantages of small wounds, minimized post-surgery pain, and quick recovery. Most important of all, it provides patients a much better quality of life.

Holding our excellent specialties and the belief of global village, we give all we can as healthcare provider and educator. Our technologies and experiences will be replicated and shared with the world continually.

Professional leadership renowned internationally

Taiwan's healthcare standards are highly recognized internationally. In addition to cardiovascular disease, Taiwan also plays a leading role in the fields of liver transplant, cancer therapy and reconstruction surgery. The highly developed medical technology was ranked by National Geographic as No.1 in Asia, No.3 Worldwide. Furthermore, our national health insurance was recommended by Nobel Prize for Economics winner Paul Krugman.

       In order to introduce Taiwan's medical technology to the world, the Ministry of Health and Welfare will organize the “Taiwan International Healthcare Pavilion” at Taiwan Healthcare+ Expo to showcase the achievements we have, including greatest proton center in Asia, cellular therapy technique, advanced health check tools like CT, MRI, PET scan, and so on. 

Taiwan Healthcare+ Expo will be held at the Taipei Nangang Exhibition Center on 12/5-8. Welcome to join us and discover the secrets behind the excellence.

The topic of this year’s symposium focuses on generic drug regulations. In this symposium, representatives from each country share their updated generic drug regulations in a one-day workshop and a one-day public symposium. Due to the rapid growth of emerging market in ASEAN countries, international pharmaceutical companies are prompted to enter. However, the differences in drug regulations and languages often restrict the industries from entering the market. In order to facilitate the global development of the commercial opportunities for Taiwan’s pharmaceutical industries, TFDA designs several topics such as regulatory framework of drug quality control, and updated regulatory requirements for generic drug registration etc. in 2-days activities. Furthermore, TFDA also arrange a face-to-face reception, which provides a sharing and consulting opportunity for regulators and industries.  

Through the in-depth and comprehensive information exchanges in the Taiwan-ASEAN Drug Regulatory Symposium, TFDA hopes to promote communication and cooperation with ASEAN countries, and helps the industries to explore the commercial opportunities of the domestic pharmaceutical industry in the new southbound market, thus to create a mutually beneficial situation.

The New Southbound Policy plays an important role in Taiwan's economic and trade strategies, and the implementation outcome has received high social attention. TFDA promotes mainly through "training the professionals from new southbound countries", "regulatory harmonization" and "regional industrial chain collaboration". TFDA also devotes itself to domestic pharmaceutical and food industry development for entering new southbound markets. TFDA hopes to build mutual trust and benefit by strengthening bilateral relations with new southbound partner countries and creating a win-win, which aims to redefine Taiwan's position in Asia and even in the global community.

The deliverables of this conference include reaching and enhancing the mutual understandings of the regulatory information and the collaborations between regulatory authority and industries, helping the industries from both countries to have the advantage of entering international markets, and securing the public health in both countries.

Since the “Framework of the Cooperation on the Medical Products Regulation” was signed by Taiwan-Japan Relations Association and Japan-Taiwan Exchange Association in November 2013, TFDA works with MHLW and PMDA to establish working groups and host Annual Joint Conference in alternative turns for seven years.

Under this cooperation framework, the pharmaceutical and medical device working groups between TFDA and MHLW/PMDA continue to conduct cooperation activities, personnel exchange and short-term training programs. Working groups also jointly discuss about management, regulations and technical issues for medical products. The topics include new drug review regulation, implementation of the relevant guidance of the International Conference on Harmonisation (ICH) and constructing a novel co-review mechanism, etc. After the “Memorandum of Cooperation between the Japan-Taiwan Exchange Association and the Taiwan-Japan Relations Association on the field of Medical Device Quality Management System Requirement” was signed on November 30^th 2018, both sides will cooperate to share and exchange the medical device Quality Management System (QMS) audit reports and the QMS compliance certifications. These collaborations and activities are expected to reduce the marketing barriers for both Taiwanese and Japanese manufacturers and promote the development of the industries in both countries.

TFDA has long been participating in the APEC LSIF-RHSC to promote the regulatory convergence. In July 2017, TFDA and RAPS Taiwan Chapter were formally regarded as an APEC Regulatory Science Training CoE in the area of GRM. Since then, TFDA has been hosting the training events for the third consecutive year in Taiwan. In the future, TFDA will keep hosting the GRM training courses to achieve the goal of promoting regulatory convergence, capacity development and international cooperation.

Narcotic analgesics, including fentanyl, morphine, oxycodone and other opioids, are often used to treat moderate or severe pains, such as those caused by cancer and chronic non-cancer condition. However, these narcotic analgesics exhibit high potential for abuse and addiction, governments have reinforced the management over controlled drugs by licensing systems and scheduling management and to prevent them from entering the market and trigger abuse.

The conference invites a lineup of international speakers, including Dr. Michael Evans-Brown of the European Monitoring Center for Drugs and Drug Addiction (EMCDDA); Jeffrey M. Connors, Aziz Elkholy and John A. Pacella of the U.S. Drug Enforcement Administration; Yusuke Kanazawa, Chief, intelligence section of the Pharmaceutical Safety and Environmental Health Bureau under Japan’s Ministry of Health, Labor and Welfare; and Dr. Weerawat Ukranun, Director of Thanyarak Maehongson Hospital, under Thailand’s Ministry of Public Health. They will shed light on the abuse of narcotic analgesics in their countries, and the preventive measures being taken. The conference has also invited Dr. Chih-Peng Lin, Chief of the Division of Pain Medicine, Department of Anesthesiology, National Taiwan University Hospital, to share his insights on related issues in Taiwan from a clinical perspective.

About 150 exports from the medical communities and public health regulators will participate in this event. By serving as a platform where experts can share and discuss experiences, the conference seeks to improve regulations and administration guidelines on narcotic analgesics and, ultimately, ensure public health and drug safety.

 As for inspection standards, the Regulations on Good Hygiene Practice for Foods (GHP), waste disposal and product labeling, the second stage project will look more deeply into the legality of food additives, and sample pickled vegetable products to run tests on content such as preservatives and bleaching agents, etc. Through enhanced inspection and testing, it is expected that the hygiene and safety of the food products can be increased and the source of food better managed.

 TFDA urges food businesses to supervise themselves more by following the “Act Governing Food Safety and Sanitation” and emphasizes that any use of food additives must comply with the “Standards for Specification, Scope, Application and Limitation of Food Additives”. If deficiencies of GHP are not corrected within the deadline or finished products not in compliance with the regulations, a fine will be given as punishment to safeguard the health and rights of consumers.

To increase the diversity of topics, the agenda is divided into five major sessions: "Analytical Techniques for Pesticide", "Analytical Techniques for Veterinary Drug Residues", "Analytical Techniques for Non-Targeted Analytical Approaches & Food Additives", "Analytical Techniques for Rapid Screening & Identification" and "Risk Assessment Related & Others". Moreover, 14 oral presentations and 73 posters are also presented. The topics of the event include analytical techniques for pesticides, veterinary drugs, heavy metals, biological species identification, microbes, genetically modified foods, food additives and food adulteration.

Through this conference, the TFDA exchanges analytical techniques and experiences with experts from food-analytical field, hopes to enhance the testing ability and quality of the national laboratory and local health bureaus, and makes contribution to create a comprehensive quality and safety protection network of food in Taiwan.

Mr. Liu was frequently aroused from sleep at midnight, and he suffered from habitual snoring, loud snore, awakening with dry mouth, daytime drowsiness, as well as other symptoms. Loud snoring also bothered his wife from sleeping well. In order to understand his physical status, Mr. Liu decided to go to hospital for diagnosis. A sleep study arranged by the doctor revealed that Mr. Liu had been suffering from Severe Obstructive Sleep Apnea Syndrome with Apnea Hypopnea Index (AHI) of 55 events per hour. After an evaluation of his clinical symptoms, together with the anatomy of the upper respiratory tract and comorbidity analysis, his doctor recommended him to use Continuous Positive Airway Pressure Device (CPAP Device) during sleep. By adhering to the CPAP therapy, Mr. Liu’s breathing became regular and he stopped snoring at night. With a better sleep quality, he felt wide awake every morning.

    Sleep Apnea is a disorder in which an individual's breathing stops and starts repeatedly during sleep. Air cannot get into the lung and blood oxygen content is reduced. Patients might arouse from sleep and this may lead to severe impact on sleep quality. There are three main types of Sleep Apnea: Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA) and Mixed Apnea. Obstructive Sleep Apnea is the most common type. Causes of OSA might include excess weight, anatomical factor in upper respiratory tract (e.g., nasal septum deviation, turbinate hypertrophy, nasal polyp hyperplasia, elongated uvula, tonsils enlarged and tongue hypertrophy) which blocks the nasal passage. Clinical symptoms of OSA may include snoring, frequent urination at night, awakening with dry mouth, headache, daytime sleepiness and impaired concentration. Treatment choices of OSA are surgery, wearing mandibular advancement device, or using Continuous Positive Airway Pressure Device during sleep, etc. Doctors will prescribe appropriate therapy according to patients’ condition and sleeping habits.

    Continuous Positive Airway Pressure Device therapy is very common for the treatment of OSA. The principle of the machine is to send a positive pressure flow using the internal motor to ensure that airway stays open during sleep. Some CPAP devices are designed to identify patients’ breathing condition using pressure or flow sensor to modify the applied pressure or flow. Others have designs that might include humidifier delivering warm and moist air to reduce irritation. Besides daily functional test, essential cleaning and maintenance of the CPAP device to see whether the applied pressure should be adjusted, TFDA recommends you to return to your doctor for regular check-up visits in order to ensure proper therapeutic effect. All the CPAP devices that have been issued medical device licenses are evaluated and approved by TFDA. The effectiveness and safety are ensured before legally marketed in Taiwan.

TFDA reminds you to consult your doctors before using the CPAP device, and follow the steps below. First, you should recognize whether the product is classified as a medical device. Second, you have to read the labels, instructions for use and packaging carefully, so as to confirm whether the manufacturer’s name, address, product name, registration number, batch number, manufacturing and expiry dates are clearly marked. Lastly, you should read the user manual thoroughly and strictly follow all the instructions to make sure that you have chosen the appropriate medical device and used it correctly. For more information related to medical devices, you can consult your doctor or visit the database at http://www.fda.gov.tw/MLMS/H0001.aspx. If you notice any device-related problems or adverse event after usage, please report at http://qms.fda.gov.tw, or call the adverse reaction reporting phone line at 02-2396-0100.

This conference is held according to the TFDA’s annual plan of Analytical Techniques Harmonization of Cosmetic Products and Cooperation with New Southbound Countries. Focusing on the topics of cosmetic analytical techniques, emphasizing the cooperation with new southbound countries and enhancing the connection between Taiwan governments, industries, academic and research institutes and the cosmetic markets in new southbound countries, the conference aims to achieving a final goal of protecting the customers’ safety. In addition to inviting the southbound countries’ experts from Malaysia and India to share their experiences in cosmetic analysis and management, the TFDA also invites the experts from the National Institute of Health Sciences (NISH) in Japan, the Eurofins laboratory in Italy and Taiwan to share the latest developments in cosmetic analytical techniques. The TFDA also shares the development experiences and achievements of cosmetic analytical techniques in Taiwan.

Through this conference, the TFDA exchanges ideas with multinational experts to learn from each other's relevant analytical techniques and experiences to help enhance the competitiveness of Taiwan’s industry in the international market, and to promote more collaboration with the world in the field of cosmetic research and analysis techniques.

The conference presents an impressive lineup of international speakers and topics. In the international NPS trend viewpoint, Dr. B. Vicknasingam, from Universiti Sains Malaysia, will introduce the NPS global prevention strategy; Dr. Masahiko Funada from National Center of Neurology and Psychiatry, Japan, will introduce the harmful physical effects of NPS. About the updating prevention policy, Dr. Linda B. Cottler from University of Florida, USA, will introduce the solution to the American addiction problem; Dr. Kiyoshi Wada from Saitama Prefectural Psychiatric Hospital, Japan, Dr. Hee-Sun Chung from Chungnam University, Korea, and Dr. Yih-Ing Hser from the University of California, Los Angeles, USA will following share Japan, South Korea and USA NPS abuse prevention strategy. The local speakers will also introduce the current situation, challenges and strategies of NPS abuse in Taiwan and exchange the implement prevention policy of NPS abuse with international experts in their respective countries in this two-day conference.

The conference is expected to attract over 180 guests from health care, law enforcement, and judiciary circles. Through sharing the valuable experience, discussing the toxicity and novel treatment of NPS and exchange of best NPS practices in this conference, we try to  achieve the goal of effective control and prevention of NPS to safeguard people’s health.

Cleaning and disinfection procedures validation on facilities and equipment as well as proper design of personnel and material flows are measures on cross contamination control in shared facilities. Chapters 3 and 5 of PIC/S GMP and guideline of health based exposure limits (HBEL) are both requirements to follow. This PIC/S expert circle meeting emphasizes the practical experience as the most important learning way and arranged workshops and case studies throughout the three days to allow the inspectors to brain storm the possible sources of cross contamination, to discuss the potential risks and difficulties during inspection, and share experience. The meeting also output suggestions for inspection tools including PIC/S guidelines and aide memoir.

This event was successfully concluded and all participants give positive feedback on the input of Taiwan FDA and appreciate the support from PIC/S. This CCCISF Chairman Mr. Graeme McKilligan noted in the closing remarks his special thanks to Taiwan FDA colleagues for organizing and hosting this meeting. He recognized the participants from the world all enjoyed the three-day productive meeting. Besides new knowledge on inspection is able to take home, the participants were surrounded by the warm hearted people and learn the culture and hospitality of TFDA. Taiwan FDA once again accomplished its mission in international diplomacy.

This event marked a continuation of the successful partnership between Taiwan FDA and PIC/S. Additionally, to ensure our regulation and management system moves in line with the international standard, Taiwan FDA will remain actively engaged in the global community to raise its international profile and boost our international competitiveness.

 The focuses of inspection in this project included the compliance with the Regulations Govering the Registration of Food Businesses, the Regulation on Good Hygiene Practice for Food (GHP), iced desserts and related products sampling and testing. The testing items included indicator bacteria, preservatives, colorants and maleic acid and maleic anhydride. Those who were found to be violating provisions of the Act Governing Food Safety and Sanitation would be dealt according to the law.

TFDA reminds consumers to pay more attention to the hygiene of staffs on-site, the operation sites, and the containers while purchasing iced desserts. Consumers are advised not to purchase products at insufficiently cool storage temperature. Once purchased, iced desserts should be consumed as soon as possible or preserved properly to prevent bacteria growth. TFDA also recommends food businesses to implement self-management by following the Act Governing Food Safety and Sanitation to ensure food safety and sanitation, and protect the health of  consumers.

Invited speakers of this meeting are from health authorities of pharmaceutical leading countries such as UK MHRA, US FDA, Germany BfArM and Italy AIFA. It should be noted that Mr. Graeme McKilligan from UK MHRA, the chairman of PIC/S CCCISF expert circle, who leads the revision of PIC/S GMP Guide and implementation of EU Health Based Exposure Limit (HBEL) Guideline. He will share the latest requirement on cross contamination prevention when the drugs are produced in shared facilities. Other topics include how to perform and effective cleaning base on risk assessment and toxicology assessment, and the result should be able to demonstrate that there is no risk of contamination. It is expected that inspectors can understand the sources of cross contamination and conduct inspection effectively and scientifically. More importantly, achieve harmonized international GMP standard.

The PIC/S is the assembly of GMP inspectorates leading the global harmonization of GMP standard for medicinal products, and establishes this CCCISF expert circle in 2017. The first meeting of this expert circle is hosted in Taipei by TFDA, represent that TFDA is highly recognized  by the global community. Moreover, TFDA expects the meeting outcome could be contributed to the revision of aide memoire  to assure global medicinal product safety.

These two technologies were developed by a team led by Dr. Chia-Hsien Hsu of NHRI’s Institute of Biomedical Engineering and Nanomedicine. The related lines of research began in 2012 after Dr. Hsu noticed problems with monoclone culture for antibody therapy. To improve the situation, Dr. Hsu’s team designed a highly efficient cell-manipulation technique that can be used to capture single cells and subsequently culture them into monoclonal cell groups. This important finding not only was published as the cover story of the Royal Society of Chemistry’s journal Lab on a Chip in 2015 but received the National Innovation Award in 2018. By using a combination of the microfluidic dual-well device and the selective particle transfer method developed later, researchers can manipulate and culture single cells highly efficiently without expensive machines or repetitive manual operations.

OriGem Biotech is founded in 2016 that focuses on microfluidic chips for biomedicine. Since 2016, NHRI and OriGem Biotech have cooperated with each other on many projects and developed a strong working relationship.

      Successful biomedical technology transfers such as these are made possible by the government’s promotion policies and leadership of the Ministry of Health and Welfare.

The abuse of NPS has become a global challenge. Drug dealers attempt to evade inspections and crackdowns by modifying the chemical structures of existing illegal drugs to create NPS. As a result, the variety of NPS has grown in the past few years, making control and screening of them difficult increasingly. This is also the case with illicit drugs, which come in myriad forms. Recent years it have seen a number of incidents in Taiwan involving illegal food and drugs, such as counterfeit Crestor tablets or faked Cialis and Viagra. For example, TFDA analyze the ingredient of Acetaminophen, Ibuprofen in counterfeit Viagra .This important public issue gives rise to a host of health threats and social problems, which Taiwan seeks to address it. 

By organizing the workshop, the TFDA hopes to work with a number of health agencies, the Customs Administration, and law enforcement in using advanced analytical technologies to stem the spread of NPS and illegal drugs. The workshop will serve as a platform for exchanging views and sharing the results of analytical technologies related to NPS and illicit drugs for experts. In so doing, we hope to enhance our analytical technologies, fortify drug abuse prevention systems, and, ultimately, protect the health of our citizens and drug safety.

The world we are living in is faced with the challenges of extreme climate and complex humanitarian emergencies. The World Health Organization (WHO) has been emphasizing the importance of regional cooperation for disaster preparedness and response. Since the 7-magnitude Chi-Chi earthquake occurred in 1999, Taiwan’s government officials have been constructing disaster response systems within communities locally as well as building disaster medical assistance teams nationally. Meanwhile, non-governmental organizations, such as the Taiwan Root Medical Peace Corps, the Red Cross Society of the Republic of China, the Buddhist Compassion Relief Tzu Chi Foundation, and the Taiwan Development Association for Disaster Medical Teams, have also been sparing no effort in enhancing the ability of disaster rescue personnel. They actively participated in humanitarian aid both domestically and internationally. Their presence has been seen in various disasters abroad including the 2004 Indian Ocean tsunami, the 2010 Haiti earthquake, the 2011 Japan earthquake, the 2015 Nepal earthquake, and the 2018 Indonesia earthquake.

Minister Chen states that the Disaster Medical Assistant Team (DMAT) of Switzerland possesses numerous substantial experiences regarding the domain of disaster medicine. In 1999, right after the disastrous 7-magnitude earthquake struck Taiwan on September 21^st, Switzerland’s DMAT, as well as Dr. Olivier Hagon, the Deputy Head of Division of Tropical and Humanitarian Medicine at Geneva University Hospitals, was here to help. A strong bond has developed between Switzerland and Taiwan ever since. 20 years after the occurrence of Chi-Chi earthquake, we marked a historic moment by signing the MOU with the Geneva University Hospitals.

Minister Chen points out that the main agenda of the MOU includes:

1. Supporting the setting-up of the EMT initiation under WHO standards.
2. Enriching the contents of EMT training courses/programs
3. Supporting other medical domains of Disaster Medicine and Primary Care;
4. Enhancing cooperation in the academic research of disaster medicine between both sides, and data analysis as well.

Disasters strike humanity without regard for borders. Disaster preparedness and response require collaboration and integration across national boundaries, especially when faced with global climate change, armed conflicts, and outbreaks of infectious disease. The world needs a universal language and system to respond to crises, and no political interference should be directed towards humanitarian aid. Taiwan should not be dismissed from international networking. By cooperating with the Geneva University Hospitals and organizations from other countries, we can not only improve our own disaster response capacity but also contribute our part to saving lives whenever a disaster or emergency event happens in any corner of the world. Just as the slogan of the Taiwan WHA Action Team says: Health for All, Taiwan Can Help.

  World Health Organization (WHO) has proposed the theme of “Oral Health for a Healthy Life”, which means that oral diseases have a significant impact on the overall health. For example, periodontal disease is bilaterally correlated with diabetes and the number of teeth in mouth is inversely related to the risks of dementia. Therefore, oral problems should not be taken lightly as problems that affect only part of the body. As Taiwan becomes an aging society, integrated care that includes oral care has become a pressing need. As a result, oral health issues must be taken into considerations when the government drafts policies related to the overall health promotion.

  The agenda for the Conference covers topics such as public oral health policies for all age groups, the correlation between oral and other diseases, and dental care issues. The two-day conference is expected to attract more than three hundreds local and international dental specialists and public health scholars.

  Director-general Wang of Health Promotion Administration, Deputy Director-general Tsai of National Health Insurance Administration, and Deputy Director-general Lee of Social and Family Affairs Administration are invited to discuss important oral policies in Taiwan in the Conference, such as quitting smoking and betel nut chewing, health care effectiveness of the National Health Insurance system, and the implementation of denture subsidies for seniors. International guests of honor are also invited, including Bettina Borisch, representative of World Foundation of Public Health Association; Raman Bedi, professor at the Dental Institute of the King’s College, London; and Hideo Kawahara, senior dentist at the Japan Society of Aesthetic Dentistry, to talk on topics related to public oral health.

  It is noteworthy that representatives from The World Federation of Public Health Associations will bear witness to the signing of Taiwan Health Declaration by Minister Chen of Health and Welfare on the opening ceremony, which will open up a new chapter for Taiwan’s oral health care.

The abstract of Declaration:

1. Apply a „‘health & oral health‘ in all policies“ approach in the whole-of-government & whole-of-society actions in prevention & control of NCDs; take consequences and benefits in oral health into consideration in health impact assessment.
2. Integrate oral health screening, prevention and promotion into the planning and delivery of primary health care to assure equitable and holistic provision of oral health for all.
3. Integrate oral health into health promoting services and activities in all types of settings, such as nurseries, schools, workplaces, long-term care institutions, army, prisons, etc.
4. Integrate oral health into holistic health and vice versa in professional education, training and research.
5. Integrate oral health into the efforts for legislative action on general public health including the legislation on tobacco control, harmful alcohol use, nutrition and obesity prevention, UHC, etc.
6. Explicitly demonstrate syndemics of oral, general and social health throughout the life course in public health education, training, policy development, actions and evaluation.

  It is hoped that the quality of oral health promotion in Taiwan will be elevated through the exchanges and sharing in the Conference. The Ministry also aspires to provide more comprehensive oral health care for the pubic by keeping up with the advanced countries in terms of oral health policies.

　　Agenda of the Conference:

According to the related surveys in Taiwan, foodborne disease outbreaks often occur in summer. During this season, the public should   pay more attention when consuming foods. It is better to preserve or store food at low temperature (no higher than 7℃) as soon as possible, in order to keep it fresh and prevent the growth of bacteria that might cause foodborne diseases outbreaks. Meanwhile, TFDA would like to remind all the consumers of the higher risk of foodborne disease outbreaks when consuming raw seafood. Hence, cooking seafood (especially shellfishes) thoroughly is highly recommended. Furthermore, equipment and utensils, such as knives and cutting boards, for handling raw materials should be separated from those for prepared foods to prevent cross contamination. Food handlers and consumers should also wash their hands with soap and rinse by clean water before handling food and before meals.

TFDA provides and advocates “Five keys to get away from foodborne disease” as follows:

1. Wash: wash hands with soap, and rinse by clean water before handling food and before meals.
2. Fresh: ensure the cleanness of water, and select and keep freshness of foods.
3. Separate: equipment and utensils for handling raw materials should be separated from those for prepared foods.
4. Cook: prepare and cook foods thoroughly, at least to 70°C of the core temperature.
5. Preserve: keep foods at low temperature (no higher than 7℃) or preserve them in adequate means, and do not leave food at room temperature too long.

Dr. Lin’s research discovered, that one hour of smartphone use during the day delays circadian rhythm by 3.5 minutes and decreases total sleep time by 5.5 minutes. Smartphone use before bedtime was only around 14.3% of total use, but had around 44% of the impact on sleep. Previous literature shows light exposure significantly impacts circadian rhythm. Dr. Lin’s research team demonstrated that use before bedtime significantly affects circadian rhythm. The research results have recently been published in the March 2019 issue of the Journal of Psychiatric Research.

The research team comprises researchers from National Health Research Institutes (NHRI), National Taiwan University Hospital, Mackay Memorial Hospital, Chiao Tung University, and Dan Jiang University, with expertise in the fields of psychiatry, psychology, statistics, electrical engineering and computer science. The investigation utilized the “Rhythm” app and continuously collected smartphone use data for 14 days along with a questionnaire. A significant amount of data was collected and analyzed for use patterns and sleep times.

The method in which the “Rhythm” App collects sleep and use data is based on the times of the screen turning on and off. Most importantly, Dr. Lin’s team is the first one to propose “proactive use” (turning on the smartphone, making phone calls, using applications) and “reactive use” (receiving calls, receiving notifications) in their analytical algorithm to predict sleep times and to precisely calculate the impact of smartphone use on sleep times. Statistical analysis shows our methodology has 84% correlation to results from the user questionnaire.

Dr. Lin notes that most apps currently on the market must be manually set and the users have to wear or place the devices bedside in order to monitor and record behavior. Once the user forgets to set, wear, or properly place the device, the data collection will be interrupted. The “Rhythm” App is completely automatic and collects data continuously and calculates sleep times from this data. The App is also power efficient.

Dr. Lin also notes that the “Rhythm App” can continuously and automatically record use patterns and sleep times over long periods, and therefore can be utilized for sleep and health monitoring. In addition, the “Rhythm” App can precisely calculate smartphone use and its impact on sleep, and the collected data from the App is more objective then a user’s self-report or questionnaire. The “Rhythm” App is considered to be a breakthrough in research methodology, and will have great application potential in the fields of sleep medicine and psychiatry.

For the full text of our publication in the Journal of Psychiatric Research, please visit: https://www.sciencedirect.com/science/article/pii/S0022395618309038

TFDA publishes the noncompliance products information weekly on the “ The Food and Drug Consumer Zone ” (website: http://consumer.fda.gov.tw/index.aspx) / Integrated query service / Food / Border inspection not conform food information inquiry zone. The information contained product name, importer and exporter (company name and manufacturer), reasons for failure, quantity and follow-up situation. The release of information will facilitate the public to understand the noncompliance products.

TFDA urges that food business shall do well self-management and import products meet Act Governing Food Safety and Sanitation. Otherwise, the products could be stucked on border, and the cost and business reputation would be lost.

Dr. Shu-Li Wang of the National Health Research Institutes (NHRI) collaborates with Dr. Ming-Tsang Wu, Dr. Mei-Lien Chen, and Dr. Chia-Jung Hsieh in a birth cohort study named the Taiwan Mother Infant Cohort Study (TMICS). The TMICS group found significant associations between urinary phthalate metabolites and the use of PCPs, particularly leave-on PCPs, using structured questionnaires and repeated measures of urinary phthalate metabolites throughout the pregnancy. Because of the short half-lives of phthalates, it is hard to capture the temporal variation of phthalate exposure during pregnancy. A strength of this study lies in the use of repeated urinary phthalate measurements throughout pregnancy to reduce exposure misclassification.

In summary, the research team indicated that with the increasing use of skin toners, lipsticks, and essential oils, individuals are exposed to higher concentrations of mono-ethyl phthalate (MEP). Additionally, a positive trend was found regarding the number of leave-on PCPs used and the measured change in MEP concentrations. Other positive associations included mono-benzyl phthalate (MBzP) and body lotions.

Moreover, new systems such as the establishment of product sources & flow data and serious adverse effects & hazards reporting are included, and the amount of administrative fines is greatly increased. The penalties for violating cosmetic advertising are also increased, for those who have severe violations will be required to publish corrective advertisements and withdraw their products so that the consumer rights will be protected with more sound regulations.

Since the presidential promulgation of the new Act, Taiwan Food and Drug Administration (TFDA) has announced a number of draft subordinate laws, announcements and supporting measures, including Enforcement Rules of the Cosmetic Hygiene and Safety Act, Regulations Governing Notification of Cosmetic Products, Regulations for Cosmetic Product Information File Management, and Regulations for Labeling of Label, Leaflet and Packaging of Cosmetics, etc. TFDA will collect public comments and announce relevant regulations in accordance with legal procedure.

According to TFDA, the implementation of Cosmetic Hygiene and Safety Act will create a new era for cosmetic management system which is in line with international regulatory trend. It is TFDA’s intent to elevate the safety, stability and quality of cosmetics and to help enhance the international competitiveness of local cosmetic industry.

“1-2-3 simple steps to reading nutrition labelling: 1. Check servings per container. 2. Consider the calories. 3. Choose the nutrients wisely.” The first step is to check the servings per container on the nutrition labeling. The nutrition labeling provides types of information based on “per 100g/ml” or  “daily percentage reference value,” and both measurements must indicate the content of calories and nutrients “per serving.” The second step is to determine the number of servings you are actually consuming and then multiply by the number of calories per serving which is total amount of calories consumed. The third step is to carefully select the nutrients you need based on your dietary needs. The nutrition labeling contains information about the level of calories, carbohydrate, protein, sodium, saturated fat and other nutrients that most people are concerned. Daily percentage reference value can quickly help you to realize the amount of calories and nutrients that the food contributes to a total daily diet which is 2000 calories based on a daily diet.

In addition, when shopping for prepackaged food products, pay attention to the following: Carefully examine food product packaging that is not damaged, and making sure the products have clearly labeled information on ingredients, expire date, contact information of manufacturer, country origins, and nutrition labeling. Although the content of ingredients does not need to be labeled, but the ingredients must be listed in descending order by weights starting by the ingredients that weight the most to the ingredients that weight the less. It is also necessary to check the products the expiry date.

New year represents a new beginning where as people would like to enjoy a happy and healthy life. TFDA reminds you to read the label on prepackaged food products to make smart food choices over the Chinese New Year.

APIs are the key components of medicines. To ensure the drug quality, all imported APIs need to comply with GMP standards. The reinforcement of border controls can strengthen the management of APIs at the border, so as to prohibit counterfeits. Furthermore, Executive Yuan launched the “New Generation Anti-drug Strategy” to block the sources of illicit drugs. Border inspection of APIs can be one of the effective actions. 

Randomly-selected batch will be examined by rapid test instruments “Raman Spectrometer” at customs. Once the imported items are determined to be illicit drugs, they will be forwarded to the judicial/police authority for further investigation. If the characteristics of the imported items cannot be identified, they shall be sealed and stored at the GMP compliant sites immediately. After the applicants have prepared the assurance statements and the supporting documents, the TFDA will assign staffs to the storage sites and unseal the items for further examinations.

Manufacturers should proactively prepare all the relevant documents and apply for inspections from the TFDA in order to enhance drugs supply chain integrity and also fight against illicit drugs.

The benefits of establishing the Medical Devices Act are threefold-internationalization, soundness, and specialization. As the separate management of drugs and medical devices has already become an international trend, this Act is harmonized with laws and regulations in various countries around the world, so that Taiwan’s medical device industry is able to connect seamlessly with global countries. To address a diverse range of medical devices and a wide variety of research and development (R&D) and manufacturing processes, regulatory mechanisms would be enhanced based on the life cycles and risk management principles of each type of product. For instance, new systems such as a registration system to be implemented for low-risk medical devices, and the flexible approval of permit validity period, will not only accelerate the time to market for products and bring benefits to patients, but also drive the development of industry. In addition, the new Act will list those who design medical devices and launch such devices to the market in their own names as manufacturers. This not only protects the interests of designers, but also encourages the industry to invest in R&D. Using the Medical Devices Act as a single source of law would allow for the planning of medical device regulatory system as a whole and the governance from design, manufacturing, and all the way to distribution and use.

Establishing the Medical Devices Act not only improves various measures that enhance the safety, effectiveness, and quality of medical devices for safeguarding the health and safety of the public, but also serves as an endeavor to improve the quality of domestic medical device industry, strengthen international cooperation, as well as offer regulatory consultation and counseling of industry projects, thereby assisting businesses in going international. At present, the draft has been reviewed by the Legislative Yuan. The TFDA will strive to improve the Act and actively communicate with all sectors. It looks forward to garnering support from all stakeholders in the hope that this Act can be officially implemented as soon as possible, and that a new era can be created for the development of Taiwan’s medical device industry.

With strong support from international friends, domestic experts and scholars, GHF Taiwan is marching towards its 14th year. It has won a good international reputation and successfully built up the Taiwan brand. This year, as many as 12 ministerial and vice-ministerial level officials from diplomatic allies and friendly nations are participating in the event, with 68 distinguished guests and internationally renowned experts, the highest in number so far. Among them are representatives from 34 countries including Kiribati, Palau, Haiti, Nauru, Russia, Saint Kitts and Nevis, Saint Vincent, Saint Lucia, Myanmar, Tuvalu, Thailand, Singapore, Japan, eSwatini, Vietnam, Nicaragua, Solomon Islands, Philippines, United States, Australia, Austria, Belgium, Switzerland, United Kingdom and Malaysia. Additionally, in the area of international health, leaders in various health fields are also attending, including the World Federation of Public Health Associations (WFPHA), the Union for International Cancer Control (UICC) and the United States Agency for International Development (USAID), highlighting the close relationship of Taiwan with global health networks and the extent of international recognition of Taiwan’s health achievements.

Resilience is one of the priority development policies of the World Health Organization (WHO) to improve health for all. It also plays an indispensable role in achieving the United Nations Sustainable Development Goals (SDGs). The theme of 2018 GHF Taiwan, “Resilience: New Challenges and Opportunities for Global Health”, plans discussion from global, regional and national perspectives; its parallel forum will explore the current status and future planning in various countries, including international experiences of health emergency response systems, the recovery of mental health resilience after disasters, the global perspective on human impact and mass reaction to the HPV vaccination program, the retrospection and outlook for oral health care for the elderly, health knowledge and health care for the elderly, health promotion issues from the perspectives of global health or the Asia-Pacific region, and the global disease burden as resources for decision making - experiences from global networks, etc. The MOHW said that by holding this regular, annual forum, our country is able to discuss issues of international concern with officials and scholars from all over the world. Through interaction and discussions from multiple angles by the industry, government and academia worldwide, it hopes to unlock a new vision of sustainable development of health, and provide references for the formulation of our health policy. For relevant agenda and information about the forum.

The TFDA also supports the clinical trial training program yearly which consists of two types of training courses, which are the basic training and the advanced training. The basic training courses focus on fundamental concepts including Good Clinical Practice, research ethics, and quality of trials. The advanced training courses focus on further learning and discussion for specific topics, such as “Early Phase Clinical Trial for Drug Development” and “the Implementation of Monitoring Clinical Trials”. The subjects’ protection activities focus on the correct concepts for clinical trials as well as the rights and responsibilities of the subjects. The approaches include lessons and adventure games to introduce basic concepts of clinical trials to the publics.

In the future, TFDA plans to establish an online learning system for helping more people understand clinical trials and the rights of those involved. In the meantime, TFDA will continue to perfect the environment of clinical trials and strengthen the protection of subjects.

In this conference, TFDA invites experts knowledgeable in Singapore, Malaysia and Thailand to be speakers for introducing the latest 3D printing, implantable medical device and the current situation of the ASEAN medical device market in these countries. It is hoped that this will help medical device manufacturers to better understand the medical device research and development of these countries, and thus enhance the international cooperation and marketing, as well as not only strengthen the competitiveness in global market for Taiwan medical device industry but also promote cooperation in evaluation technology in the field of biomedical engineering.       

“The Joint Conference of Taiwan and Japan on Medical Products Regulation” is one of the communication platforms under the “Framework of the Cooperation on the Medical Products Regulation,” which was signed by “Taiwan-Japan Relations Association” and “Japan-Taiwan Exchange Association” on November 2013.  Taiwan Food and Drug Admistration (TFDA) and Japan Ministry of Health, Labour and Welfare (MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA) have formed several working groups, through which Taiwan and Japan have been communicating and exchanging information about pharmaceutical policies and regulations regularly. Taiwan and Japan have also co-organised annual conferences alternatively. This year is the sixth year of the collaborations.  

Under the framework, the working groups included activities such as two-sided official visits and observations, as well as discussions and comparisons of some of the highly interested topics in new drug regulations and review standards. Taiwan and Japan also co-organised a workshop on the 8th May this year to share regulatory updates for bioequivalence studies. In addition, Taiwan and Japan is currently constructing a novel co-review mechanism and on the preparation of signing MOC for the Medical Devices as well.  TFDA looks forward to shortening the review times for medicinal products and medical devices and helping Taiwan industries to prosper. 

More than 30 international experts were invited to deliver training in good review practices or good submission practices, including experts from German regulatory authority BfArM, Japan regulatory authority PMDA, UK regulatory authority MHRA, and several other institutions. The total number of participants is expected to be more than 120, including participants from 15 APEC member economies and 2 European Union member countries. This workshop is hosted by TFDA and co-organized by Regulatory Affairs Professionals Society (RAPS) Taiwan Chapter, APEC LSIF-RHSC, Pharmaceutical and Medical Device Agency (PMDA) and Asia Partnership Conference of Pharmaceutical Associations (APAC).

APEC is a premier economic forum in the Asia-Pacific region. TFDA has long been participating in the APEC LSIF-RHSC to promote (GRM). In July 2017, TFDA and RAPS Taiwan Chapter formally became an APEC Regulatory Science Training Center of Excellence in the area of GRM. Since then, the CoE has delivered an annual training event with focus on the best practices of good review and good submission. Established by APEC Leaders in 2002, the LSIF has since grown to become APEC's leading initiative on health and health sciences innovation. The LSIF Leadership recognizes Taiwan’s important contributions to the LSIF workstreams over the years and nominates Minister Shih-Chung Chen of the Ministry of Health and Welfare to succeed the chair of the LSIF Executive Board this year in August. Hosting this event has deepened and consolidated Taiwan’s international relations through capacity building, exchanges and cooperation, and added another highlight in Taiwan’s pharmaceuticals affairs after becoming an official member of ICH this year.

Following on from Taiwan FDA’s successful hosting of the PIC/S Committee Meeting and Annual Seminar last year, this year it hosted the highly technical PIC/S Expert Circle Event on QRM in Taiwan. This event has been highly regarded by inspectors, offering in-depth keynote speeches and abundant case studies to facilitate discussion. The event enables inspectors worldwide to engage in intensive brainstorming and discussion, improve and strengthen their inspection skills, develop and draft related QRM technical documents that integrate knowledge and experience from around the world for use in future inspections, incorporate QRM principles into inspection systems, and maximize inspection resources. At the same time, open discussions allow inspectors to set the direction of future training sessions in order to meet current needs.

This event marked a continuation of the successful partnership between Taiwan FDA and PIC/S. Through the efforts of Taiwan FDA and with the full support and assistance of PIC/S, the PIC/S Expert Circle Event on QRM produced fruitful results and was widely acclaimed by all participants. Dr. Karmin Saadat, Chair of the PIC/S Expert Circle on QRM, especially extended his sincere gratitude to Taiwan FDA for its hospitality which enabled guests from all over the world not only to enhance their professional knowledge through the three-day event, but also to experience the culture and passion of Taiwan. Taiwan FDA once again accomplished its mission in international diplomacy.

Taiwan FDA has committed itself to PIC/S activities since its accession to PIC/S in 2013 in order to consolidate its membership in PIC/S and deepen its relationships with other members. In addition, Taiwan FDA has taken on the great responsibility of hosting PIC/S events several times and has assumed an increasingly indispensable role in PIC/S. In the future, Taiwan FDA will remain actively engaged in the global community to raise its international profile and boost Taiwan’s international competitiveness.

In recent years, there were complicated and varied food and drug safety incidents happened in Taiwan, such as excessive residues of veterinary drugs or pesticides in food and adulteration of food and drugs. It damaged domestic economy and international image. TFDA has long fought illegal products using source management, enhanced inspections and scientific evidence. Furthermore, we keep handling the development of international innovation analytical techniques and knowledge immediately to meet the need of management. In order to enhance the capabilities of analytical techniques and to be in line with international levels, TFDA organized “2018 APEC Workshop on Food Safety and Food Adulterated with Drugs”.

In this workshop, a number of international experts have been invited to share the analytical techniques and experience on the two themes of “Analytical Techniques for Food” and “Analytical Techniques for Illegal Drugs”. In the first section, the topic includes analytical techniques for pesticides, veterinary drugs, mycotoxin, food contaminants and genetically modified food. In the second section, the topic includes drug adulteration, unknown identification, the alert system of illegal products and other topics. TFDA expects through this workshop to be helpful for enhancing Taiwan's analytical capabilities. Also, this workshop has got the support of APEC, which promotes international communication and establishes a bridge for cooperation with the southbound countries.

The PIC/S Expert Circle Event on QRM aims to provide inspectors of medicinal products with advanced and consistent QRM training programme, to enable them to critically inspect the implementation and use of Quality Risk Management during regulatory inspections, effectively inspect QRM activities on site and use the PIC/S Recommendation in relation to risk-based GMP inspection planning, maximize inspection resources, conduct inspections more effectively, and ensure the safety of medicinal products.

This event includes a 2-day training course and a 1-day Expert Circle meeting. Internationally renowned experts, senior GMP inspectors, and experienced speakers from the industry have been invited from countries including the U.S., the U.K., Austria, Ireland, Iran, and Taiwan, and participants are key talents nurtured by GMP inspectorates worldwide. The curriculum is designed under the QRM framework, and consists of keynote speeches and multi-theme workshops, involve the topics of principles, tools and examples related to the implementation of QRM in industry, risk identification, data integrity etc. This event also provide a platform for participants to exchange information, share experience, revised related guidance documents and map out future plans for inspector training.

The quality of medicinal products has a significant bearing on people’s health and safety, and Good Manufacturing Practice (GMP) is a key component of quality management. PIC/S is the most authoritative and the only international organization made up of GMP regulatory authorities in the field of medicinal products. It aims at harmonising inspection procedures worldwide by developing common standards in the field of GMP, from the materials, manufacturing process, storage, transportation, to distribution. PIC/S currently comprises 52 Participating Authorities from 49 countries in America, Europe, Asia, Africa, and Australasia. Taiwan FDA has become a Participating Authority of PIC/S since 2013.

Expert Circles have been set up by PIC/S to facilitate the discussions and the exchange of information among inspectors specialised in a specific area of GMP. Expert Circles meet regularly to develop draft guidance, recommendations, etc. and offer training in their respective fields of specialisation. Given that the supply chains of medicinal products are becoming increasingly complicated, QRM has been widely utilized in the pharmaceutical industry in order to identify and control potential risks and improve the decision making. The PIC/S Expert Circle on Quality Risk Management (QRM) was established in 2007. It has been active in developing models for QRM systems for Inspectorates as well as guidance on the assessment of QRM implementation in industry. Expert Circle meetings and training activities are held regularly to offer comprehensive training to inspectors to enable them to inspect QRM systems in a harmonised manne

In this conference, TFDA invites experts knowledgeable in Vietnam, Philippines, India, and Indonesia regulations to be speakers for introducing the latest regulatory status of medical devices in these countries. It is hoped that this will help domestic manufacturers to better understand medical device regulations of other countries, and thus enhance the international cooperation and marketing, as well as strengthen the competitiveness in global market for Taiwan industry. 

TFDA has been promoting the New Southbound Policy implemented by the Executive Yuan since 2016. It is anticipated that by utilizing the advantages of Taiwan’s soft power in medical field, a beneficial foundation can be established for strengthening the international partnerships between Taiwan and the New Southbound countries, thereby achieving bilateral and multilateral cooperation with ASEAN, South Asia, New Zealand and Australia, as well as creating regional development and prosperity.

At the time when the legislative procedure of Taiwan’s Medical Devices Act is being promoted by TFDA, ASEAN and India are also implementing regulatory innovations during the same period. Through interactions with New Southbound countries in this conference, experiences may be mutually shared and the capacity of regulatory exchange between Taiwan and New Southbound countries may be further enhanced. This will also assist Taiwan’s medical device industry to learn about the latest implications of their medical device regulations, further understand regulatory changes, and help manufacturers to export and sell products to the international market.

Following the format of the first symposium in 2017, events scheduled will include: face-to-face workshop, public seminar, and site visiting for the research and analysis laboratory of TFDA and the domestic pharmaceutical industries. TFDA and the representatives from the industry will share Taiwan’s current drug regulations and the development of biomedicine in these workshops. ASEAN representatives will explain their domestic drug regulatory policy in the public seminar.

TFDA hopes to enhance the communication between ASEAN countries and increase the opportunity for cooperation with the international community.

According to Malaysia’s regulations, Taiwan’s industries export products which are belonged to health supplements of Malaysia’ traditional medicine and health supplements GMP regulations are obliged to meet GMP regulations. Products can be registered in Malaysia only after NPRA assigns people to do inspection in Taiwan or Taiwan’s industries provide a certification in English accredited by TFDA which fulfills the requirements of Malaysia’s traditional medicine and health supplements GMP regulations. However, since last September Taiwan industries who pass verification of “the secondary tier quality control” and“food expansion verification program” will be issued a certification by TFDA to prove that they meet traditional medicine and health supplements of GMP regulations in Malaysia. Then they are able to directly submit applications regarding inspection and registration against NPRA in Malaysia to shorten time and reduce cost of export.    

Until June 2018 there is one company, who benefits from the previous mechanism to export its products to Malaysia. After that, four Taiwan’s companies have passed “the second tier quality control” and “food expansion verification program” and they are going to apply for inspection registration against Malaysia very soon.

TFDA not only helps industries to export products to New Southbound countries smoothly, but also continuously raises the overall quality of hygiene and safety management system in domestic food factories to ensure that manufactures are all able to comply with the relevant regulations of Law Governing Food Sanitation, keep safeguard food safety and sanitation seriously.

To conform with international expectations, the “Taiwan Dementia Policy: A Framework for Prevention and Care 2.0” proposed by the Ministry of Health and Welfare references the “Global Action Plan on the Public Health Response to Dementia 2017-2025” proposed by the World Health Organization (WHO) to promote the following seven strategies: (1) Prioritize dementia in public health promotion; (2) raise public awareness and acceptance of dementia; (3) reduce the risk of dementia; (4) establish a robust dementia diagnosis, treatment, and care network; (5) universalize support and assistance for home-based dementia caregivers; (6) create a dementia data collection and analysis platform; and (7) promote dementia research, innovation, and development. Several cross-council meetings were held to discuss the formulation and implementation of 19 action plans.

As of the end of May 2018, 34 daycare centers offer dementia care services, and 21 veteran homes and welfare institutions operate dementia departments, collectively offering 1,012 beds. Nine nursing homes and 26 ministry-registered hospitals provide dementia services, collectively offering 997 beds. In terms of community care, 72 Integrated Dementia Care Centers (IDCC) have been established in the city as of the end of June, assisting suspected dementia cases in seeking medical assistance, raising public awareness and acceptance of dementia, and fostering dementia caregivers at various locations. Moreover, 333 Support Center for People with Dementia and their Families (SPDF) have been established across the city to promote awareness, organize dementia-alleviating activities, and train home caregivers and support groups (counseling and consultation). The aforementioned resources are invested in hopes of improving the quality of life of dementia patients and their caregivers and providing them with necessary care services and support.

To fully implement dementia policies and management/supervision mechanisms, each action plan contains a set of quantifiable and measurable indicators. The Ministry of Health and Welfare holds periodic review meetings each year to ensure the implementation and completion of the action plans and relevant tasks and monitor the development of dementia in Taiwan. We welcome the public to learn more about the Taiwan Dementia Policy: A Framework for Prevention and Care 2.0, and help us build a “dementia-friendly Taiwan!”

 Additionally, the Cosmetic Hygiene and Safety Act was promulgated by our president on May 2nd. To assist industry to be fully aware of the future management in Taiwan, TFDA also address the key directions of the Act. The main direction is to include non-pharmaceutical toothpastes and mouthwash products into cosmetic management, and the industry should comply with the requirements of Product Notification System, Product Information File (PIF), and Good Manufacturing Practice (GMP). To ensure the use safety of consumers, TFDA will strengthen post-market inspection and the autonomous management of cosmetic industry.

It is TFDA’s intent to let industry learn more about the trend and differences of international regulatory management, and to help Taiwan’s local cosmetic industry of reaching global stage via this Symposium.

Drug Information Association (DIA) has served as an international organization and their members include: government regulatory agencies, science, research, and development, CRO companies worldwide. The DIA annual meeting is the largest meeting of drug developers, manufactures and regulatory agencies that provides opportunities in advanced scientific and medical innovation. 2018 Global Annual Meeting was held during 24th-28th June at the Boston Convention & Exhibition Center in USA. During the session of TFDA Town Hall, Shou-Mei Wu, the Director General for TFDA, highlighted the role of TFDA in regulatory management of drug development. James Chih-Hsin Yang, the Director of Department of Oncology at National Taiwan University Hospital, then proceeded to share the challenges in conducting multi-regional clinical trials and interpreting data. Churn-Shiouh Gau, the Executive Director of Center for Drug Evaluation, in her speech demonstrated the usage of real world evidence in regulatory decision making. The topic of Annie Tsu-Hui Liu, the Director of Office of the Board of Science and Technology at Executive Yuan, was about development of pharmaceutical industry in Taiwan. Other presentation topics in the profession poster session. included: prior assessment consultation for cell therapy products to enhance the investigational new drug application quality in Taiwan, the cost effectiveness of metastatic melanoma treatment in Taiwan, and an adaptive seamless phase I/II design in drug development for binary endpoints

In order to promote the communication in regulatory science, the TFDA and CDE organized the informal “Taiwan Night” event, enhancing the relationship with foreign regulatory agencies, local pharmaceutical companies and Taiwan experts in the research. Present to officiate the event was the Executive Director of DIA, Angelika Joos, Corporate Vice President of PAREXEL International, Alberto Grignolo, and the Director of General of Taipei Economic and Cultural Office in Boston, Douglas Hsu. Drug regulatory experience-sharing and the practice application in Taiwan were internationally recognized.

ICH was founded in April 1990 by the representatives of the regulatory authorities and industry associations from Europe, Japan and the US.  The goal is to promote public health through international harmonization of the technical requirements for the pharmaceuticals.  TFDA has been joining ICH related events for more than 10 years since 2008.  We not only attended regular ICH Assemblies, but also participated in more than twenty expert working groups.  In addition, we held training courses for the industries so they could learn and follow the latest ICH guidelines.  Becoming the Regulatory Member of ICH has significant meanings to TFDA as we have been working diligently to improve our regulatory environment and follow the international guidelines.  This also shows that our pharmaceutical products possess very high quality, and have been recognized by international standards.     

In the future, TFDA will continue to actively participate in the ICH related events to construct a regulatory environment that complies with the ICH guidelines.  Through the collaborations between government and industry, high-quality drugs could be manufactured.  Thus our people’s wellbeing can be assured. 

    To raise anti-drug knowledge and ability of the general population, to keep away from NPS’ harm, and to promote family harmony as well as to establish good parent-child relationship, Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare joined by other government agencies organized the “drug free home parent-child fun discovery camp”. Through lively and diverse promotion, community people are invited to learn about drug hazard prevention, parents are encouraged to accompany their children to engage in legitimate casual activities. The activities include parent participating education classes, watching anti-drug troupe performances, viewing anti-drug films, barricade breaking and quiz games. During the learning process, more parent- child interactions and better connection are established. Also speaking tour teachers are arranged in community gatherings and festival activities in order to extend anti-drug propaganda work to every family and corners of the community.

    Should you find friends or relatives with drug use problem, you can dial the free direct line for detoxification at 0800-770-885 for help. Also you can search the web for the Ministry of Health and Welfare appointed rehabilitation organizations list. Anti-drug work cannot wait, TFDA calls for all people to join in to establish drug free new home.

Firstly, TFDA provides online “Export Certificate Application Process System” to be used to address requests for different types of export proof documents for processed foods and will prompt respondents to provide the facility and product information necessary for TFDA to review and process such requests. Food manufacturers can use this system to apply sanitary certificate, test report, manufactured sanitary certificate and certificate of free sales and manufacture online, that not only helps to improve work efficiency but also detects input errors in time. The application of certificate of free sales and manufacture is comprehensive online on March 1 2018.

Secondly, Inspection will be conducted by competent authority to attest that the food product complies with standards and requirements for issuing the sanitary certificate. In Taiwan, certain food manufacturers (e.g. Canned foods manufacturers) are requested to follow the regulations of secondary verification, which includes Good Hygienic Practice (GHP) for food and Hazard Analysis Critical Control Point (HACCP) and confirmed by a certification body. For sanitary certificate application from these food manufacturers, inspection could be omitted because they have been inspected regularly under secondary verification. This could decline the fee of request application and speed up the working time of reviewing process to 10 days.

Through the new approaches mentioned above, application for an export proof document could be more convenient and less cost. TFDA encourages food manufacturers to apply export proof documents by these ways. TFDA offers a free service number 0800-676-668 that could provide more free consultations, if there are additional questions for application process.

        How can we hear sounds? When sound waves enter the path of middle ear and vibrate the eardrum, hair cells in cochlea create electrical signals, and then the auditory nerve will carry the signals to brain which turns them into sounds. Generally speaking, there are two types of hearing loss: conductive and sensorineural hearing loss. “Conductive hearing loss” is due to the structure problems with the ear canal, eardrum, or middle ear. This kind of hearing loss may possibly be improved or repaired by surgical operation, medicinal treatment, or wearing a hearing aid. “Sensorineural hearing loss” is due to damage of the inner ear, also known as nerve-related hearing loss. Most of this kind of hearing loss patients may be improved by wearing hearing aids; few of them need to be surgically treated with cochlear implants since benefits cannot be achieved from conventional hearing aids. Cochlear implant is composed of receptors, electrodes, coils and speech processers. The receptors and electrodes are to be implanted by a surgeon. The speech processer is turned on by audio therapists. Cochlear implants collect sounds by the microphone of speech processer and transfer the sounds to signals, which in turn are transmitted to hearing nerves to induce auditory sensation.

        Cochlear implants are classified as Class III medical devices that are required to be assessed and approved by TFDA. They are indicated for use in patients who have severe hearing impairment and cannot achieve success or adequate benefit from hearing aid over three months. However, before implanting a cochlear implant, there must be an evaluation process by the medical team. Some hearing-impaired patients with non-functionality of the auditory nerves and the upper auditory pathway, external or middle ear infections, absence of cochlear development, tympanic membrane perforations, and patients who are not suitable in performing middle or inner ear surgery are not recommended to implant a cochlear implant. Patients and families should fully understand what surgery process is planned, along with the risks, benefits, and other options. Also, the patient’s willingness to experience new acoustic sounds and cooperation in an auditory training program is critical to the success of the surgery.

    TFDA recommends that you discuss thoroughly with your surgeon about your overall health, your occupation, and your daily activities to choose the cochlear implant that suits you the best. Besides, be sure to strictly follow the preoperative and postoperative instructions. If you would like to learn more about your device, please consult your surgeon and visit the database at http://www.fda.gov.tw/MLMS/H0001.aspx. If you notice device-related  problems, please file reports electronically at http://qms.fda.gov.tw, or call the adverse reaction reporting line at 02-2396-0100.

1. Information exchange.
2. Technical cooperation.
3. Experience sharing on implementation of policies or regulations.
4. Holding periodical working meetings.
5. Holding professional visits and activities as workshops/conferences.

The signing of this collaboration document has successfully expanded exchanges and formalized the cooperation between the pharmaceutical regulatory authorities of Taiwan and Malaysia. Based on the signed document, TFDA will continuously to facilitate regulation harmonization, exchange of scientific detection technologies, and laboratory verification collaboration with the NPRA, to gain their trust in Taiwan’s products. By building mutual trust, TFDA hopes to reduce the duplication of tests and inspections, simplify review process, and thus shorten the time for products to enter the markets in Malaysia and other southbound countries, connecting businesses and eventually promoting the development of pharmaceutical industry within the region.

In recent years, increasing consumer awareness about accurate food ingredients is accompanied with social-economic development. Many news and researches about adulterated foods and mislabeling in fishery products, such as species mislabeling (cheaper freshwater catfish sold as John Dory fish or cod) is a serious concern by people. In 2013, the European Union announced that fish was the second-largest product at the risk of food fraud. Furthermore, fish fraud has led to more consumer disputes in the world.

    Conventional identification of raw fish species is based on morphological features, sizes, colors and shapes. Once the fish has been made into processed products (such as fish ball, fish floss, fish fillet, and etc.), the species can’t be recognized by the conventional method. In addition, consumer encountered the same situation, which they couldn’t tell the species from the appearance as they brought the part of big fish from the market. Hence makes it possible for dishonest people to take advantage of it. TFDA establishes this rapid recognition methods of fish species identification applied to detect fish raw materials, and reinforces the compliance label of commercial fishery products.

TFDA has participated in FAPAS proficiency tests for years, and passed the tests about identification for 11 species of cod, catfish and flatfish. Besides, TFDA also has published the testing methods of fish species identification about Salmo salar, Zeus faber, Thunnus spp., and the family Istiophoridae on the website (http://www.fda.gov.tw/ TC/siteList.aspx?sid=1574) as references for public use.

Continuously, TFDA bases on fundamentals of science to develop the new detection techniques of DNA molecular biological identification to ensure food quality and safety.

There are 3 parts to this 4-day conference. The first part is the training course for regulators, to introduce the WHO policies and registration of OTC medicines. The second part is the closed meeting among government officials, to discuss issues about self-care, reclassification of prescription drugs, and simplified registration of OTC medicines. The last part is an international conference opened for industries. Inside the program, each country will share their managements of OTC medicines, and invite experts to provide perspectives on future market trends. Over 200 people will join this conference.

In response to the coming of an ageing society, to improve the accessibility of OTC medicines and boost the establishment of regulations for self-care and self-medication are the key points of this Self-CARER conference. The TFDA aims to accelerate and strengthen the regulations of self-care and OTC medicines for the participating countries through the conference, to improve the environment of self-care and quality of healthy life.

The Commission of the European Union (EU) and the Council of Europe created a network of official medicines control laboratories (OMCLs) in 1994. The network is composed of the full member (EU member) and the associated member (non-EU member). The member in the network could continually upgrade the levels in controlling the quality of medicinal products by the information exchange and resource sharing of testing method development, capability testing, and post-marketing surveillance. The official laboratories of EU, Canada, Australia have joined the OMCL network, becoming a member of GEON.    

TFDA is responsible for quality control of biologics. In accordance with the article 74 of Pharmaceutical Affairs Act, the lot release system is performed in the field of vaccines and other high-risk biologics for human use. Most of the vaccines for human use in Taiwan come from Europe country. TFDA has participated in International Collaborative Study to establish the WHO International Standards about twenty times, and also positively participated in the collaborative study on testing method and reference substance hosted by the Groups of Experts of European Pharmaceutics. Furthermore, the TFDA Division of Research and Analysis－Section of Biologics applied for membership of GEON in 2016. Through rigorous dossier review and on-site audit procedures by EDQM experts, TFDA has finally been officially notified to be an associate member of GEON. Followed by Singapore's Health Science Authority, TFDA becomes the second official laboratory in Asian countries to join this network. TFDA still strives to expand other pharmaceutical filed of laboratory attestation to improve medication safeguard.

It is a milestone that Taiwan moves forward on focusing pharmaceutical intellectual property protections. Initially, there is 5-year of exclusivity for new chemical entity and biologics. Based on the new Pharmaceutical Affairs Act, there is a 3-year of data exclusivity for a new indication with international data, and it might be extended to a 5-year protection for those with domestic clinical trials.    

After implementing the patent linkage, the license holder of a new drug is required to list patent information. It is also required that the applicant of a generic license with declaration stating that it is no infringe to its corresponding new drug, notifies the patentee and the holder of a new drug. Once patentee files the lawsuit within 45 days after receiving notification, TFDA will stay 12 months for approval. During the stay period, review process is still undergoing without any suspending. The first generic holder challenging the patent successfully will receive a 12-month of market exclusivity.

The Amendments to Pharmaceutical Affairs Act will protect the intellectual property of invention company, as we as reducing the risk of patent infringement of generic drug company. 

Ms. Cheng and her husband, the late Professor Reinhardt at Princeton University (who was a former White House advisor and member of the Science and Technology Advisory Group of the Executive Yuan due to his outstanding achievements in medical economics), had maintained a frequent presence in international conferences and published many influential academic papers on the health insurance systems of different countries over the years. They also published a number of articles about the NHI system of Taiwan in international newspapers and magazines, in which they acclaimed our success in implementing a beneficial and administratively efficient health insurance system nationwide and recommended other countries to learn from our experience.

The coverage of our NHI system on well-known international media channels, such as American Broadcasting Company (ABC), Public Broadcasting Service (PBS), and Cable News Network (CNN), was mostly provided by Ms. Cheng. In 2009, she published an article titled “Lessons From Taiwan’s Universal National Health Insurance” in Health Affairs. The article contains an interview with Yeh Ching-chuan, the founding CEO of the Bureau of National Health Insurance, which prompted him to be invited to appear before the United States Senate to introduce the merits of Taiwan’s NHI system in 2014. Yeh then became the first former official from Taiwan to testify at a United States Senate hearing. This proves that the health care network in Taiwan is in line with the standards of developed countries all over the world and has been recognized internationally.

To acknowledge the efforts of Ms. Cheng over the years in helping to promote the success of Taiwan in health insurance, to establish the NHI model of Taiwan as a benchmark, and to attract other countries to actively learn from us, as well as to recognize her enormous contributions to the improvement of Taiwan’s international image and exposure on the international stage, the Ministry of Health and Welfare (MOHW) presented the Second Grade Medal for Professionalism in Health and Welfare to Ms. Cheng and the First Grade Medal for Professionalism in Health and Welfare to Dr. Reinhardt. Certificates of appreciation were also awarded in the name of the MOHW in appreciation of their remarkable achievements over the years.

The major therapeutic areas of these approved drugs were cancer therapies, rare diseases, diabetes, cardiovascular diseases and infection diseases. Top two therapeutic areas were cancer therapies (20%) and rare diseases (11%), it is noteworthy that both of them were increased 15% and 7% separately, compared to previous year.

In 2017, TFDA launched the Refusal to File (RTF) mechanism to facilitate review process by reducing unnecessary reviews and incomplete applications. The statistical data showed that the median approval time of NCE/ biological products was 295 days. It was an obvious reduction that review time was 66 days shorter than the previous year. It is no doubt that TFDA made efforts to improve public health and meet the medical needs for all Taiwan people. 

As a new type of manufacturing skills, 3D printing has the great advantage of the ease in fabricating complex geometric structures and facilitating the creation of anatomically matched devices and surgical instrumentations. According to the reports of medical devices development in the world, many countries have started to approve 3D printed medical devices in the fields of orthopedics, dentistry, supportive device and accessory. 3D printing could help manufacturers bring their products to market more efficiently when a transparent process for future submissions is provided. For all submissions, a principal concept for TFDA’s consideration is that 3D printing is just the processing method and it should not alter the function of final products. Final products ought to comply with all the requirements of existing relevant laws and regulations of the Pharmaceutical Affairs Law.  Although there is a huge diversity of 3D printing, this guidance firstly provides a principled management suggestion to ensure the safety and effectiveness of medical devices. TFDA expects to accelerate 3D printed medical devices into the market through the regulatory announcement, and aims to establish a quality environment for industrial development to promote Taiwan's medical devices worldwide.

The CDC stated that, in order to mitigate the threat of a flu epidemic to the public’s health, prevention tasks of the responsive plan, such as reinforcing epidemic monitoring, extending the coverage of influenza antiviral drugs, enhancing the quality of acute and critical care and resource allocation and strengthening risk communication, will be constantly promoted and implemented. The CDC also reminds related authorities to strengthen infection prevention and control measures for institutions like medical institutions, army barracks, schools, and long-term care institutions and correctional institutions with high densities, so as to prevent a flu outbreak.

In addition, the CDC has distributed government-funded influenza antiviral drugs among more than 4,000 contracted medical institutions in counties and cities nationwide and reminds the public not to underrate the severity of influenza and to go to their nearest doctor or hospital if they experience flu-like symptoms. If a patient is considered to be eligible for government-funded influenza antiviral drugs based on a physician’s clinical judgment (see the eligibility criteria in the attachment), antiviral drugs can be prescribed without rapid influenza diagnostic tests being conducted. High-risk groups, including adults aged 50 and above, infants and toddlers, high-risk chronic disease patients and pregnant women, should take notice of their health conditions; upon feeling unwell, please go to a doctor or hospital as soon as possible to seize the best time for earlier treatment and lower the risk of critical conditions.

The CDC re-urges that citizens should clean their hands regularly, wear masks if they have respiratory symptoms, avoid going to crowded public places with poor air ventilation and stay home if feeling sick, in order to prevent virus transmission. Please visit the Taiwan CDC website (https://www.cdc.gov.tw), or call the domestic toll-free dedicated line for epidemic prevention 1922 (or 0800-001922) if you have any questions relating to influenza.

The ceremony officially started with the loud sound of some drums. Afterward, Minister of Health and Welfare Chen Shih-chung, Political Deputy Minister of Finance Su Jain-rong each gave their welcome speeches. During the ceremony, the “Letter of Intent for Collaborative Border Management” was jointly signed by the Director General of the Customs Administration, Liao Chao-hsian; the Director General of the Food and Drug Administration, Wu Shou-mei; the Director General of Keelung Customs Brokers Association, Cheng Shih-chi; and the Director General of the Association of Applicants for Commodity Inspection, Yuan De-long to officially implement cooperate services between the FDA and the Customs Administration for integrated border management.

According to Political Deputy Minister of Finance Su in his welcome speech, Keelung Harbor is the main customs location for importing daily commodities to Taiwan, most of which are food. Through cooperation between the FDA and Keelung Customs can help these services increase their international competitiveness. In addition to enabling the customs clearance process to be more convenient for these services, it can also strengthen the cooperation and relationships between different authorities based on its geographical advantage. As a result, a safe and convenient customs environment can be established.

Furthermore, according to Minister Chen in his welcome speech, the FDA will continue to strictly guard and check items after being responsible for the border inspection of imported food. The management system of food sources will also be emphasized before food is imported, and a unified management system from external areas and the border area to the internal area will then be established to prevent our country from importing tainted food. We expect to accomplish such goals as “Accessible Customs Clearance” and “Imported Food with Zero Risk” to protect the health of our citizens. 

As the FDA claimed, the collaborative cooperation between the FDA and Keelung Customs, which includes working together, co-inspecting imported goods, and sharing data, can speed up the custom clearance process. It can also be considered a model for other public authorities to enhance the international competitiveness of Keelung Harbor, make the WTO Trade Facilitation Agreement and WCO Coordinated Border Management workable, and create a new era of integrated border management.

There are hundreds kinds of PAHs, benzo[a]pyrene is the most toxic among them and has been classified as a Group I carcinogen by The International Agency for Research on Cancer (IARC). To protect public health, the maximum limit of benzo[a]pyrene in many food products has been included in the draft of  “Sanitation Standards for Contaminants and Toxins in Food” announced by the Ministry of Health and Welfare this year. The analytical method of benzo[a]pyrene in oil has also been open to public by TFDA. Apart from this, TFDA keeps developing analytical method in aquatic animals this year. More PAHs items that classified as the Group 2A (probably carcinogenic to humans) and 2B (possibly carcinogenic to humans) carcinogen are included in the analytical method.  QuEChERS technology is also applied to sample extraction and purification steps, which effectively simplifying the analytical procedures. In order to verify the method, TFDA participated in proficiency tests held by famous international agencies and applied the established method to analyze six PAHs items, including benzo[a]pyrene, benz[a]anthracene, chrysene, benzo[b]fluoranthene, indeno[1,2,3-cd]pyrene and benzo[g,h,i]perylene. All the results measured by TFDA were close to the assigned values announced by the organizer and were graded as “Satisfying”. These results demonstrate the good accuracy of the established method and the analytical ability of TFDA has kept pace with international standards.

The development and announcement of testing methods are the main task of TFDA. To ensure food safety, TFDA will keep participating in international proficiency tests and verifying the accuracy of the established methods and analytical techniques.

For the laboratory accreditation requirements of "Test for Food Microorganisms – Salmonella in different matrices such as salad, milk powders, soft cheese, liquid egg, chicken, chocolate, ground peppers, sprouting seeds and lettuce", TFDA has taken Food Examination Performance Assessment Scheme (FEPAS) since 2001 and TFDA passed the PT annually.

To keep improving analysis capabilities, TFDA took the initiative to challenge the PT of identifying the unknown pathogens in beef rice cooking and sponge swabs. Participants need to apprehend this outbreak and develop strategies for analysis, so as to identify the possible etiologic agents in the analyte/matrix which is simulated the food poisoning with symptoms, incubation period and the suspected food.

In the “beef rice cooking” PT, TFDA not only accurately detected Salmonella enterica subsp. enterica serovar Cerro inoculated in the matrix as the etiologic agent of virtual food poisoning but also the only organization identified the additional strains, Staphylococcus epidermidis and Pseudomonas aeruginosa. In the organizer's distribution report for the “sponge swabs” PT, TFDA was also the laboratory which appropriately identified both the causative organism: Salmonella enterica subsp. enterica serovar Cerro and background flora: Lactobacillus plantarum and Kocuria rhizophila.

Developing and proclaiming the detection methods for food is one of the major responsibilities of TFDA to guarantee food safety and quality. Over the years (2001-2017), the detection methods have been revised and updated in real time according to the trends of international methods or special needs which includes the separation and identification of strains by traditional microbial biochemical tests and molecular biology techniques (ex. Real-time PCR) for rapid identification. Base on the continued success of participating in international PT all these years, the satisfactory results show that the detection standards of TFDA are in sync with those of other countries and the detection methods are worth universal trust.

Taiwan Food and Drug Administration (TFDA) recently conducted a survey to understand the public opinions on community pharmacies. The results showed that the professional services provided by pharmacists without difference between community pharmacies and hospital. Overall, the public generally thinks that pharmacists provided services with consistency, and also recognized that the community pharmacy offered more customer-oriented services on dispensing, consultation, medicine management and home delivery service for medicines.    

Government used to educate people how convenient the community pharmacies are. With the number of community pharmacies has increased, community pharmacists gradually enter into resident’s home and deliver medication. People rely on the community pharmacists to solve medication problems and improve their health and wellness. It has been 20-years of implementing the separation of prescribing and dispensing, the functions and roles of community pharmacies, and the positive image of community pharmacists are rooted in our daily life in Taiwan.

Article 78 of the Medical Care Act provides that any change in a human research project or its contents shall be made only upon verification or approval by the central competent authority and the Institutional Review Board. As the global biotechnology industry is blooming, the MOHW is endeavoring to promote the rapid development of medical and pharmaceutical services in Taiwan. Moreover, considering the rights and interests of human subjects and the international trends in regulating human research involving investigational new drugs, the MOHW aims to implement a specialization program that enables professionals to conduct reviews based on their scientific knowledge and technical experience in their specialized area, as well as to establish various management systems according to the complexity of different cases. Thus, the amendment to Article 55-1 of the Enforcement Rules of the Medical Care Act has been proposed.

The purpose of this amendment is to provide a legislative basis that allows the verification and approval of human research projects involving investigational new drugs to be done by appointing affiliated agencies or authorizing other institutions or corporations to do so when necessary. Hierarchical management will be implemented on human research projects involving investigational new drugs and related change proposals based on their risk level . Low-risk cases will be given priority for review by other institutions or corporations upon authorization. Focus will also be placed on prevention of repeated reviews and acceleration of the human research process to achieve the desired outcomes after lifting government regulations. In the meantime, the MOHW will put more effort into monitoring the management and reporting systems, so as to provide a high quality environment for human research in Taiwan and protect the safety and rights of human subjects.

Arsenic can be divided into organic and inorganic. The inorganic arsenic is much more toxic than the organic. Additionally, arsenic and inorganic arsenic are classified as the Group I carcinogen by International Agency for Research on Cancer. The maximum limits of inorganic arsenic in rice has been included in the “Sanitation Standards for Contaminants and Toxins in Food” announced by the Ministry of Health and Welfare. In the past, inorganic arsenic could not be distinguished from organic arsenic due to the restriction of instruments. With the advance of science and technology, TFDA has established “Method of Test for Inorganic Arsenic in Edible Seaweed” and “Method of Test for Inorganic Arsenic in Aquatic Animals”. Apart from this, TFDA keeps developing “Method of Test for Arsenic and Inorganic Arsenic in Rice”. In order to verify the method, TFDA participated in proficiency tests held by famous international agencies and got excellent performance. These results demonstrate the good performance of the established method.

TFDA shows the outstanding detection technology after years of dedication. The authority will use this novel analytical method to detect total arsenic and inorganic arsenic in rice and continuously develop new analytical methods for food management to protect the public health.

Since 1 December 2015, Taiwan has relaxed the restrictions on the quantity of capsules and tablets that can be imported for personal use. If the quantity of the same product does not exceed 12 bottles (boxes, cans, bags) and the total number of products does not exceed 36 bottles (boxes, cans, bags) for a single import, there is no need to apply for inspection with the Food and Drug Administration and the Customs department must approve for release. However, items for personal use that are exempted from import inspection are not to be sold. If these items are sold, the seller will have violated Article 30 of the Act Governing Food Safety and Sanitation and will be punished according to Article 51 of the same Act.  

          The Food and Drug Administration would also like to remind the public that health supplements (capsules, tablets) cannot replace drugs. In the case of any physical discomfort, the public should seek proper medical attention to avoid delaying treatment. Before special populations (such as children, pregnant women, chronic disease patients) consume health supplements, they should seek the advice of physicians, nutritionists, and other professional medical staff. The recommended intake amount, warnings and precautions on the product label should be read before consumption. Do not overdose on the supplement. If any symptoms of discomfort appear after consumption, please immediately stop taking the supplement and seek medical attention as soon as possible.

Since the “Framework of the Cooperation on the Medical Products Regulation” was signed by Taiwan-Japan Relations Association and Japan-Taiwan Exchange Association in November 2013, Taiwan Food and Drug Administration (TFDA) has been working closely with Japan’s Ministry of Health, Labour, and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) for five years.

Other than taking turns to hold the Joint Conference every year, direct contact in pharmaceutical and medical devices working groups between TFDA and MHLW/PMDA are established to jointly discuss about management, regulations and technical issues for medical products. The topics include new drug review regulation, bioequivalence regulation and review point comparisons etc.. Personnel exchange and short-term training programs were also conducted to learn from each other.

Currently, we are working on establishing cooperation scheme on new drug pilot program and signing the Memorandum of Cooperation for medical devices, in expectation with that these collaborations and activities could accelerate the marketing authorization and expand the market for industry from both sides.

In the other hand, in order to assist industry to be fully aware of and understand the medical products regulation in Taiwan and Japan, the Conference was held every year. This year, the 5^th Conference will focus on the impact of MRCT after ICH E17 fully implement, review points of generic drugs and BE guideline in Japan, Taiwan generic industry, real-world data, evaluation of postmarket clinical benefits and risks of medium-high risk medical devices etc.. Speakers and participants are from government, industry and academia. By establishing the governmental-industrial-academic communication platform, related participants and stakeholders could share and learn from each other, and thus creating a win-win-win situation in the future.

 The press conference was hosted by Wan-I Lin, minister without portfolio of the Executive Yuan, who on behalf of the Taiwan government accepted the concluding observations from the International Review Committee. Concluding observations were presented in an introduction, recognition of international human rights treaties, and main areas of concern and recommendations. In the way of an introduction, the review committee first acknowledged the sincere efforts of the Taiwanese government in implementing the convention, as well as thanking government agencies, NGOs, and child representatives for their participation in the process.

 Overall the observations raised by the committee were inclusive of several important areas, including the prioritization of the CRC, development of a national plan of action, establishment of an independent monitoring institution, implementation of the right to non-discrimination, and protection of their freedom of expression; they also included individual sections on civil rights and freedoms, family environment and alternative care, basic health and welfare, education, culture, and special protective measures.

Lin expressed his gratitude to the International Review Committee for traveling such a long distance to Taiwan to review Taiwan’s Initial Report under the Convention on the Rights of the Child. He also extended his thanks to the NGO and child representatives for their contribution to the initial report and review meeting. During the course of the conference he promised that the Executive Yuan will urge each of its agencies to implement the concluding observations and give an account of their progress in the next report and review meeting for the assessment of relevant fields. fields.

President Tsai, during today’s open ceremony, stated that CRC is the most recognizable convention worldwide. Its implementation concerns every child on this island. With a low birth rate, children are important assets to our nation. Every effort that we make today for children will be the key to Republic of China’s sustainable development. Therefore, despite the fact that ROC is not an UN member, we still are committed to incorporating the convention in our law.

President Tsai also mentioned that since the implementation of Implementation Act of the Convention on the Rights of the Child on November 20, 2014, our nation has been voluntarily complying with the requirements of the convention. In addition to conducting a full review of our law based on the convention, we have also established the national report system, with units from all five administrative branches (Yuan) and NGOs jointly monitoring the implementation of the convention in our nation. After 33 meetings, the initial report was proposed on November 17, 2016. Even though the ROC cannot participate in national reviews of UN member nations, we still have voluntarily followed the UN’s review process and convened this review meeting to showcase our commitment to human rights. The review board’s concluding observations and recommendations will be taken into account as we review the current implementation of the convention in the country and formulate future policies accordingly to better protect children’s rights.

The international review committee will have dialogues with legislators, NGO representatives during the pre-review meeting on the first day. Child representatives from all over the island will be invited to share their minds. The second and third day are review meetings for government departments, where they will review the civil right, family environment and alternative care, basic health and welfare, education, entertainment, cultural activities, special protective measures and other aspects related to children’s rights. The concluding observations will be made on the last day of the meetings and announced at the press conference on November 24. The review meetings will be streamed live on the dedicated website (with simultaneous and sign language interpretation). If interested in the implementation of CRC in Taiwan, please visit http://www.crcreview.org.tw/.

Attachment: Meeting agenda

【Review Meetings of the ROC’s Initial Report under the Convention on the Rights of the Child (CRC)】Agenda

Date：November 20 to 24, 2017

Venue：1F, Conference Room, Howard’s Civil Service International House

(No. 30, Section 3, Xinsheng South Road, Da’an District, Taipei City, Taiwan)

Agenda

• Live streaming is provided during the complete review meeting (public sessions), for more information please visit the website below: http://www.crcreview.org.tw/

You are free to forward or post the above press release. Any questions are request, please contact us.

In general, the e-submission is not only to focus on the minimization of paper use during the exchange of information between applicants and authorities, but also to enhance the quality and efficiency of the medicinal product registration process, shorten innovated product review time.

TFDA has established an electronic platform for review and submission. In this pilot plan, it is also to provide priority review as an incentive for license holders to increase the E-PRESS utilization. Furthermore, TFDA will continue to evaluate the effectiveness of E-PRESS and revise it if necessary.  

The portal page of E-PRESS, operating manual and relevant Q&A can be found on the following link :( http://e-sub.fda.gov.tw/dohclient/Manager/Login.aspx)

This workshop is the first training event after TFDA's endorsement as the formal APEC Good Registration Management Center of Excellence. During the 3-day workshop, the invited experts and participating trainees discussed the principles of good review and good submission practices, and what measures are needed for regulators to achieve good review and what measures are needed for industry to achieve good submission through lectures, experience sharing, group discussions, and case studies. In addition, the participants also understand the current status of implementation and challenges among different APEC member economies. The participants all recognize the importance of promoting Good Registration Management for the region of APEC.

TFDA will continue to host the annual APEC Good Registration Management training events under the memorandum of understanding signed between TFDA and APEC LSIF. We hope to promote the quality and efficiency of drug registration process, shorten time-to-market for innovative medical products. The ultimate goal is to promote regulatory convergence, capacity building, and cooperation among all APEC member economies.

 This workshop is a 3-day training program with Common sessions, Reviewer-Specific Sessions, and Applicant-Specific Sessions to offer the participants the concept of GRM through training regulators from different APEC member economies. It will be more than 90 participants from 13 different countries to attend this workshop; they are mainly from regulatory authorities and industry. There are more than 30 invited speakers from Japan, Canada, UK, Singapore, Philippine and Taiwan. In addition, there are more than 60 trainees from 10 different APEC economies including Hong Kong, Indonesia, Korea, Malaysia, Papua New Guinea, Philippine, Singapore, Thailand and Vietnam.   

GRM working group will collect feedback from speakers and trainees through this Workshop to refine the GRM core curriculum and the training contents. TFDA has been participating in APEC LSIF-RHSC for years. By hosting this workshop, TFDA expects to enhance the quality and efficiency of the medical product registration process, shorten innovated product review time, and achieve the goal of promoting public health.

Transforming our world: the Sustainable Development Goals

In the September of 2015, the United Nations announced the Sustainable Development Goals (SDGs), a set of 17 targets and 169 indicators to improve the health and well-being of all, incorporating priority areas such as elimination of poverty, sustainable development in nations, cross-border collaboration and sharing of resources and strategies, and ensuring that development is shared with regions lacking necessary resources. The goals also sought to create a platform for information sharing and professional assistance, and emphasized the importance of cross-disciplinary, cross-organizational and cross-border collaboration.

Dr. Ying-Wei Wang, Director General of the Health Promotion Administration, remarked that the SDGs is an amalgamation of three important facets – “Society”, “Economics” and “Environments, and the target of “Health for All” requires the mobilization of all fields in the society. Taking Goal 3 of the SDG “Ensure healthy lives and promote well-being for all at all ages” as an example, there are 13 sub-targets encompassing 26 indicators, ranging from maternal-infant mortality rate, prevention of infectious and non-communicable diseases, to traffic accidents, universal healthcare and environment pollution. To reach these targets require concerted efforts between governments and communities, which is necessary to achieve the global target of reduction in premature deaths between the ages 30 to 70 years by the year 2030.

Sharing of insights amongst worldwide experts

This year’s forum invited experts from around the world to examine the progress of the SDGs so far and shared what actions and advocacy are employed to promote the SDGs. Prof. Michael Moore, President of the World Federation of Public Health Associations, remarked that SDGs are the most effective expression of a health-in-all international policy; Prof. Jürgen M. Pelikan, Director of the WHO Collaborating Center on Health Promotion in Hospitals and Health Care in Austria, proposed that health literacy can support implementation of different SDGs through empowerment and decreasing health gaps; Prof. Robert Smith from the American Cancer Society, stated that many national case studies have demonstrated that great access to primary health care could lead to lower infant mortality, death rates from hypertension and stroke; the optimal way to achieve well-being is through community-based and person-centered care; Prof. Martin McKee of the London School of Hygiene and Tropical Medicine pointed out while 60% of countries worldwide are expected to achieve targets on under five mortality and maternal mortality, only less than 5% are expected to achieve targets such as childhood obesity, tuberculosis and traffic injury mortality; Ms. Annette Kennedy, President of the International Council of Nurses, further highlighted the indispensable role nurses play in achieving universal health coverage and SDGs in an increasingly resource-challenged health care environment.

Efforts of the MOHW toward achieving SDGs

This year’s forum also invited many experts from Southeastern nations to discuss issues and challenges on achieving SDGs. The forum features multiple parallel sessions focusing on wide range of SDG related issues, such as the non-communicable disease targets, the elimination of tuberculosis, integrated Western and Traditional Chinese healthcare for senior populations, reforms of healthcare system, transformation of integrated care, mental and oral health. Through reflecting on the progress made so far and the discussion from many disciplines of health, it is expected that better and more innovative strategies and inspiration can be drawn from the forum, and put into practice to solidifying better partnership with the Southeastern and global communities, and making a greater stride forward toward sustainable development.

    The announcement consists of three specific enhancement measures, including establishing cell therapy/gene therapy clinical trials fast-track review mechanism, streamlining first in human trials review process, and refining the review process of clinical trial protocol amendments based on the degree of changes.

   These enhancement measures are not only to streamline the clinical trial protocol review process, but also to optimize the technical review manpower by risk management of the applications. When taking the clinical trial safety and scientific standard into consideration, these enhancement measures to reduce clinical trial protocol review time period and improve review efficiency would be beneficial to upgrade Taiwan’s global capacity and competiveness of clinical trials. In addition, a new 30-day clinical trials fast-track review mechanism was established for those cell therapy/gene therapy clinical trials which fulfill with one of the following requirements: multiregional and non-first in human clinical trials (conducted in both one of the ten medical advanced countries and Taiwan), or investigator-initiated academic clinical trials with the same investigational products that had been used in other clinical trials in Taiwan.

TFDA will have a continuously review on the clinical regulatory environment such as reviewing system and reviewing efficacy to facilitate the process of getting new drugs to the market. The ultimate aim is to make people have timely access to new drugs.         

          To reach the goal previously mentioned, TFDA takes actions as follows: actively analyzing the changes of laws and regulations on medical product management in South Asian countries, holding conferences, providing training courses for pharmaceutical regulation harmonization, inviting speakers from ASEAN members to share key updates, encouraging the industry representatives to share experiences in expanding markets southward and the difficulties faced, as well as creating a webpage with information of medical product regulations of southbound countries. Under the practices taken by TFDA, there are some positive outcomes, such as: PIC/S GMP certificates and inspection results issued by TFDA are recognized by fellow members, including Malaysia, Singapore etc.; medical devices obtaining TFDA’s registration licenses apply to simplify review in Indonesia, Viet Nam, Pakistan and Sri Lanka; reports issued by three laboratories in Taiwan are accepted by Indonesian government.

             TFDA will continue to extend connections with officials in southbound countries to further advocate regulation harmonization and facilitate recognition of laboratory reports, hoping to increase Taiwan’s competitiveness, promote medical product sales overseas, and more importantly, play a key role in fighting for the prevention of food adulteration and counterfeits sales within Asia Pacific region.

IOLs have been used for several decades. The lens materials include polymethylmethacrylate (PMMA), silicone, and hydrophobic acrylate. IOLs provide the refractive power in place of the natural lens to focus light onto the retina and restore clear vision.

There are several different surgical techniques used in cataract surgery. Phacoemulsification is the most widely used method. It involves the use of an ultrasonic handpiece equipped with a titanium or steel tip. The tip vibrates at ultrasonic frequency to sculpt and emulsify the cataract while the pump aspirates particles through the tip. After cataract extraction procedures, an IOL is placed into the remaining lens capsule. With the short procedure time and the local anesthetic, phacoemulsification cataract surgery can be done on an outpatient basis. The micro incision prompts faster healing and helps to restore clear vision quickly. As with any type of surgery, there are risks associated with cataract surgery and the IOL placement, e.g. corneal endothelial damage, endophthalmitis, and retinal detachment. And the most common postoperative complications are secondary cataract and IOL decentration.

The design of IOLs has been progressed from conventional rigid spherical lens to the latest foldable multifocal aspherical lens, reducing the healing time and improving the visual acuity. There are a wide variety of IOL types. Patients should consult doctors to choose the type of IOLs by considering personal lifestyle and specific visual needs.

Intraocular lenses (IOLs) are medical devices that are required to be assessed and approved by TFDA. The premarket review will include for biocompatibility, sterilization validation, and performance (such as power measurements, light transmission, image quality and so on) to ensure the effectiveness and safety. Only TFDA-approved IOLs are legally allowed to be marketed in Taiwan.

TFDA recommends that you fully discuss with your surgeon about your overall eye health, your occupation, and your daily activities to choose the IOL that suits you the best. Besides, be sure to strictly follow the preoperative and postoperative instructions. If you think you may be experiencing an adverse reaction that may reasonably be regarded as surgery-related or lens-related, check with your eye care professional immediately. If you would like to learn more about your devices, please visit the database at http://www.fda.gov.tw/MLMS/H0001.aspx. If you have device-related  problems, please file reports electronically at http://qms.fda.gov.tw, or call the adverse reaction reporting line at 02-2396-0100.

According to the result of the 2011 epidemiologic survey of dementia conducted by the Taiwan Alzheimer’s Disease Association and sponsored by the Ministry of Health and Welfare (MOHW), and the population statistics from the Ministry of Interior Affairs, among 3,192,477 people aged 65 & over, there are 586,068 people (18.36%) with minimal cognitive impairment (MCI), 253,511 (7.94%) with dementia. People with dementia (PWD) are estimated to be 1 in 13 for people aged 65 & over, and 1 in 5 for people aged 80 & over.

MOHW pointed out that a myth about dementia is to regard dementia as a result of natural aging, and lost the opportunity of early treatment. Lack of knowledge of dementia may cause unknown fear, and lead to stigmatization and discrimination of PWD. Therefore, we are responsible to raise dementia awareness and knowledge in our society, and to improve people ability to recognize early signs of dementia for early diagnosis and treatment. Facing the escalation of dementia population, we need to take actions to reduce the risk of dementia. Protective strategies include mental stimulation, physical exercise, social activities, and Mediterranean diet. Preventive strategies include prevention and treatment of hypertension, diabetes and high cholesterol, smoking cessation, head injury, and depression.

MOHW stated that an innovation in the government’s Long-term Care Program version 2.0 is to establish the Integrated Dementia Care Centers (IDCC). IDCC is responsible to assist people to get a diagnosis of dementia and for case management consultation, as well as public education about dementia literacy, construction of dementia friendly communities and public communication about dementia care. MOHW has targeted to raise dementia literacy in the future four years, and to adapt the major indicators of the World Health Organization global action plan on dementia. Dementia awareness activities throughout the country and information about the 20 IDCCs have been posted on the MOHW website for public access.

For more information, please contact:   

Tel.: 02-85907100  cell phone: 0937-553-433

The topics of the Symposium will be focused on three most pioneering categories of devices: combination products, active implantable medical devices, and exoskeleton robot devices. With an esteemed gathering of regulatory experts from Europe, the U.S., Japan, China and Taiwan, the Symposium will feature a high-level exchange of information and experiences on the clinical trial and premarket registration for innovative medical devices. In order to protect people’s health and safety, the R&D of such devices must comply with the requirements of related international standards and regional regulations. Through the discussions among global regulatory experts, attendees will receive an in-depth understanding of the regulatory science of innovative medical devices.

The Symposium is looking forward to bringing together of passionate and creative participants from industries, official, hospitals, academic and research institutes. The Symposium will benefit the development and time-to-market of innovative medical devices in Taiwan.

Web site: https://college.itri.org.tw/SeminarView2.aspx?posno=5B5D0852-A90F-4313-822B-D256E1B53C83

The Taiwan Food and Drug Administration, Ministry of Health and Welfare (Taiwan TFDA) became a participating authority of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2013 and has actively engaged in the PIC/S affairs and events ever since to consolidate its membership in PIC/S and deepen friendships with other countries, and be the host authority of 2017 PIC/S Committee Meeting and Seminar in Taiwan. Last year Taiwan FDA was handed over the PIC/S walking stick, which symbolizes responsibility and honor, from the previous organizer, Medicines and Healthcare Products Regulatory Agency (MHRA), in the U.K. With the efforts made by Taiwan FDA and the full support of PIC/S members, global inspectors gathered in Taipei and had intense discussions and exchanges on “Quality Control Laboratories: How to Inspect.” The development of revising the “PIC/S Aide Memoire on Inspection of Pharmaceutical Quality Control Laboratories”, an important guideline on inspection of international quality control laboratories, marks a significant milestone in this seminar. The seminar climaxed with Dr. Shou-Mei Wu, Director-General of TFDA, passing down the PIC/S walking stick to Ellen Morrison, Assistant Commissioner for Medical Products and Tobacco Operations, U.S. FDA.

Taiwan started to implement pharmaceutical GMP in 1982 and has been looking up to the U.S. and Europe to improve pharmaceutical technology since two decades ago. As Taiwan being a member of PIC/S since 2013, and the fully adopted PIC/S GMP Guide to the biotech and pharmaceutical manufacturers in 2015, the efforts Taiwan has made in providing high quality drugs is well recognized, and upgrading the manufacturing techniques to reached a whole new level, on a par with international standard, which is acknowledged by major international pharmaceutical companies. In addition, the GMP certificate issued by TFDA is also recognized by South East Asian countries, Australia, Sweden, Switzerland, Canada, and etc. The 2017 PIC/S Committee Meeting and Seminar was highly praised, making Taiwan an indispensable partner in PIC/S. Taiwan FDA will keep extending its influence in the global community and deepening its partnerships with countries worldwide to let Taiwan FDA gain a foothold in the world and to market domestic pharmaceuticals worldwide.

The initial idea to set up the drug relief system is based on humanitarian. At the planning stage, government learned the experiences from German and Japan, which are the first two countries with drug relief system and took both countries as our reference models. It is worth mention that Taiwan has becoming one of the countries which has the Drug Injury Relief System.   

Due to the drug injury relief system, government is able to do further analysis on those drug relief cases. The most frequently reported adverse reactions are skin disorders, and two of typical syndromes that Stevens–Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are associated with higher risk of death or disability. It is also to find out the drugs lead to cause serious skin disorders such as anticonvulsants (carbamazepine, phenytoin etc), antibiotics, non-steroidal anti-inflammatory drugs ( mefenamic acid、diclofenac、ibuprofen etc.), and allopurinol.

To remind everyone, the severe adverse reactions are occurred unexpectedly, even if you take the drugs properly. When your friends or family members unfortunately have severe adverse reactions, please let them know to apply for Drug Injury Relief within three years from the date when they know it. For further information regarding the Drug Injury Relief, please contact us at 02-23584097.

The President’s administrative order issued on November 9, 2016, amended partial article contents of Statute for Control of Cosmetic Hygiene that shall be implemented on November 9, 2019. Based on the requirement of Paragraph 3 in Article 23-2 of the Statute, cosmetics manufacturers, importers or sellers shall not subject animals to testing when conducting safety evaluation of cosmetics or cosmetic ingredients, unless the ingredient is widely used and its function cannot be replaced by other ingredients, or is necessary to conduct animal testing due to having evaluation data that demonstrate the potential for harming human health. The regulations governing its application procedure and other matters to be complied with shall be prescribed by the central competent authority.

On February 2, 2017, MOHW promulgated the draft of “Regulations Governing the Application of Animals Testing for Cosmetics or Cosmetic Ingredients” for public consultation. The final version of the Regulations that is now issued has taken opinions from every sector during the consultation period as references for modifying the draft’s title and contents. The main contents that have been formulated include: documents to be submitted when applying for animal testing on safety assessments of cosmetics or cosmetic ingredients; procedures for supplement or correction and refusal of acceptance; notification to applicants by the central competent authority about review results and reasons for revoking or repealing approval documents of those who conduct animal testing; applications no longer accepted for the next two years after approval documents revoked or repealed by the central competent authority; documents to be submitted when applying for reissue or renewal of approval documents.

For more detailed information of the Regulations, please visit the website of Executive Yuan Gazette Online, or the page on “Latest Info.” of “Laws and Regulations of MOHW” at the website of MOHW, or visit the “Announcement” of “News Rooms” at the website of Taiwan Food and Drug Administration.

Taiwan FDA has passed the Re-Certification Audit  under ISO/IEC27001:2013 and CNS27001:2014 ( 3-year proof of  ISMS ) , as well as the ECSA (EuroCloud Star Audit ) Four Stars yearly tracking Audit on August 9, 2017.  An independent certification body confirmed that Taiwan FDA’s  ISMS (Information Security Management System) for information systems and cloud services continue to operate as specified and intended, so as to ensure the quality of its cloud services and fulfil the information security goals on confidentiality, integrity, and availability.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was founded by European countries in 1970 and presently comprises 49 participating authorities from 46 countries in Europe, Africa, America, Asia, and Australia, to lead the harmonization of GMP regulations and consistency in inspection standards of medicinal products. The PIC/S GMP Guide for medicinal products is considered the most rigorous standard in the world. Although national conditions vary in all participating authorities, pharmaceutical manufacturers should comply with PIC/S GMP Guide and be authorized by participating authorities. Taiwan FDA broke the diplomatic and political impasse, became a participating authority of PIC/S in 2013 ahead of Japan and South Korea., and going to host the PIC/S Committee Meeting and Seminar, the biggest PIC/S annual event, in 2017.

To begin with, PIC/S Committee Meeting is held on Sep. 11th and 12th, to discuss with the development strategies and projects for harmonizing the GMP regulations and enhancing the international collaboration, including reviewing the progress of work plans on revising the standard, global inspector training, and membership application of Iran, Turkey, and Mexico. Representatives from Russia and Saudi Arabia are also invited to the Committee Meeting to express their interest in becoming PIC/S participating authorities. The Chairperson, Deputy Chairperson, and Chairs of Sub-Committees of PIC/S in 2018-2019 will also be elected. TFDA is running for the position of PIC/S Sub-Committee and actively engage in the PIC/S affairs and events to consolidate its membership, raise its international reputation, and enhance international cooperation with other participating authorities via PIC/S platform.

After that, PIC/S Seminar will take place from Sep. 13th to 15th, which is the grandest annual gathering of PIC/S that brings together global GMP inspectors to discuss pharmaceutical GMP. The theme of the seminar is “Quality Control Laboratories: How to Inspect”. Quality Control is part of GMP which is concerned with sampling, specifications, testing and release to ensure that the necessary and relevant tests are actually carried out and materials and products will only be released for use and supply until their quality has been judged to be satisfactory. Discussions involve the latest GMP requirements, out-of-specification (OOS) and out-of-trend (OOT) investigation, data integrity, technical transfer of test methods, and inspection skill of quality control laboratories at pharmaceutical manufacturers. The participants will benefit from the keynotes speakers from the U.S., the U.K., France, Australia, Canada, Singapore, and Taiwan, accompany with workshops discussion to defining more comprehensive quality standards and improving inspection regulations and skills, which in turn benefits the general public.

The Deputy Minister Chi-Kung Ho of Health and Welfare and Dr. Shou-Mei Wu, Director-General of Taiwan FDA, will attend the PIC/S event to deliver opening remarks at the opening ceremony of PIC/S Seminar 2017. The GMP inspectors from Taiwan FDA have also been fully engaged. By working and discussion together with inspector globally will more valuable to our inspector to ensure that the high quality drugs are available to all patients, which in turn also contributes to not only the improvement in the quality of medicinal products but also the reputation of Taiwan pharmaceutical industry.

Please find further information from the followed website:
PIC/S (https://www.picscheme.org/en/pia-pic-s-training-seminars) and
2017 PIC/S Seminar (http://pics2017.org.tw/site/page.aspx?pid=901&sid=1148&lang=en)

Appendix: Welcome Video of the PIC/S Seminar 2017
https://www.picscheme.org/en/pia-pic-s-training-seminars

       A massive number of NPS have hit the market in recent years. The huge variability of NPS’ chemical structures means that it is more challenging for regulators to prosecute and indict the miscreants involved. Different types of NPS are also often mixed and packed into tea bags, instant coffee packs, drinks or cigarettes. This kind of packaging let people’s guard down and accidentally fall into the trap of narcotics.

       NPS poses significant risks to human health and society. According to the United Nations Office on Drugs and Crime (UNODC), there has been an accumulated 739 NPS reported from 2009 through 2016. The number of newly reported NPS has also seen a gradual growth annually. Therefore, UNODC has urged all countries to address the abuse of NPS and enforce appropriate control and management measures.

       The 2017 International Conference on New Psychoactive Substances presents an impressive lineup of international speakers, including,

• Terrence L. Boos, Section Chief of the Drug & Chemical Evaluation Section, US Drug Enforcement Administration
• Jeffrey M. Connors, Diversion Regional Manager, US Drug Enforcement Administration
• John A. Pacella, Diversion Investigator, US Drug Enforcement Administration
• Heesun Chung, Dean, Graduate School of Analytical Science and Technology, Chungnam National University, South Korea
• Yuet-Wah Cheung, Distinguished Professor and Academic Head, Department of Sociology, Hong Kong Shue Yan University

The international speakers will share updates on the prevalence and control of NPS in their respective countries and discuss the harm and treatment of NPS. The exchange of best practices and perspectives will help align Taiwan’s substance control measures with international standards and achieve our goal of effective control and prevention of NPS to safeguard people’s health.

Health food must be manufactured according to a product formula low in fat, sodium and sugar, a guiding principle in conformity with the national food and nutrition policy to ensure the overall nutrition value of the product. Excessive free sugars intake poses risks of obesity, metabolic syndrome, and cardiovascular diseases. For this reason, the MOHW decides to restrict the free sugars content in health food by imposing an upper limit. The World Health Organization recommends that for a person consuming approximately 2000 kcal per day, the amount of free sugar should be less than 10% of total daily energy intake, which is equivalent to 50 grams. Therefore, the MOHW regulates the product formula of health food by providing in the Health Food Registration Review Guideline, as newly amended on July 17, 2017, that the amount of free sugars added to health food products shall not exceed 25 grams (50% of the daily sugar limit). Health food products that contain more than 17 grams of free sugars (1/3 of the daily sugar limit) shall include the following health warning: “Based on the product recommended amount of intake (XX gram/ml), the product contains XX gram of added free sugars. Please watch your energy intake.”

The MOHW has started promoting reduction of sugar in health food several years ago. As of the date, the MOHW has approved about 400 health hood products, all of which comply with the limitation on free sugars content. According to the existing regulations, health food may claim the following 13 health care effects, including “protecting bone health”, “regulating blood lipids”, “reduce body fat formation”, “protecting the liver”, “regulating the immune system”, “postpone aging”, “regulating the gastrointestinal tract”, “regulating blood sugar”, “anti-weariness”, “regulating blood pressure”, “adjuvant modulating allergic constitution”, “protecting teeth health”, and “promoting iron absorption”.

 PPCD was moved to Sanxia District, New Taipei City in 1955, and the existing plant, built in 1988, conforms to current international PIC/S GMP standard. Limited by the old facilities, the existing plant is unable to meet the increased demand of narcotic drugs for pain control and increase the production capacity sufficiently. Therefore, the new pharmaceutical plant which conforms to the PIC/S GMP standard was built.

 The new sevenstory plant has 2 basement floors, and a total floor area of approximately 7144 square meters (2161 pings). The design was built according to Green and Intelligent Building specifications and hopes to get certification for these. The main space includes clean zones for laboratories and manufacturing as well as materials storage rooms, . The plant has established two production lines as backup. After passing the PIC/S GMP assessment in the near future, the new plant will start production to increase the PPCD production capacity and pharmaceutical quality.

 PPCD is committed to steadily and sufficiently provide safe and high-quality Schedule I and Schedule II controlled drugs. In addition to continue improving the quality of pharmaceutical production, PPCD is dedicated to the research and development of new pharmaceutical forms and new products. The production capacity of the new plant is efficiently utilized to increase the production rate of Schedule 1 and Schedule 2 controlled drugs.

TFDA has approved of five mosquito repellents as OTC drugs after the evaluation of safety on these products. It largely increases the convenience for people to purchase these products.

It is summer season, and more and more people use mosquito repellents to prevent mosquito bites. There are several things people should keep in mind when using these products, particular the OTC drugs. It is important to read package inserts and follow the instructions before using these products. Secondly, the spray type of repellents should be used at a distance of 10 to 15 cm and not be applied to eyes, mouths, wounds, or irritated or sunburned skin. Sunscreen should be used before repellents 5-10 minutes prior to lessen skin irritation. When used on children, apply repellent to parents’ hands first and then rub it on the child. Don’t use such products on children less than six months old.

If the product gets in one’s eyes, please flush the eyes slowly with plenty of water for at least 10-15 minutes. Some people may have skin irritation, or any uncomfortable situations after using these products, please stop using them immediately and consult with a medical professional or pharmacist for further evaluation.

The so-called top three Daylily Mountains, which are located in eastern Taiwan, are carpeted with blooming golden Daylily blossoms every year, from midsummer to early autumn. The freshly picked Daylily buds can be processed into a specialty product, called “Dried Daylily”. In early times, the harvest of fresh buds was processed by sulfite (a sort of eligible bleaching agent) immersing and solar drying for the purpose of long term preservation. However, the usage of bleach was too tricky to control and had no feasible quality assurance method before putting the product on the market. Therefore, the residual level of sulfites was usually found exceeding the regulatory limits (not more than 4.0 g/kg calculated as residual SO₂). The residual sulfites could cause asthma or other allergic reactions in some people. “Dried Daylily” has been a critical issue for the general public for many years.

To relieve the situation, the TFDA established a strategy to “hail legitimacy and stand against illegality”. The collaboration between central and local authorities oversaw all relevant commercial activities, including those of producers, suppliers, and restaurants. The specific topics included: (1) Developing a safer or sulfite-free processing technique and introducing it to farmers; (2) Creating a quick sulfite screening method for the quality assurance of products; and (3) Promoting the “Taiwan Daylily Logo” and QR Code to trace the product supply chain and establish brand reputation. Furthermore, to reduce the number of disqualified products, in addition to enhancing management of sources, the local authorities should frequently sample products from high-risk sales in their jurisdiction. Disqualified products can prompt investigation into their sources, a recall of suspicious products, and penalties imposed on those responsible. After a five-year endeavor among central and local authorities, the qualification rate of dried Daylily products has risen from 57.7% in 2012 to 88.4% in 2016.

The relevant sanitary food safety agencies will continue surveillance over this product to strengthen management at the source and introduce business entities with the QR Code to trace production. Furthermore, penalties will certainly be imposed on those producers and processers violating the regulations that ensure food safety for consumers.

As the effect of whistleblowing incentives and protection in Taiwan’s food safety regulations heightens, the number of report has seen a sharp increase. In addition, high profile food fraud cases have pushed up inspection demands. For instance, as the recent news of a food trader selling expired frozen meat using deceptive labeling made the national headline, TFDA raised the frequency of walk-in freezers inspection. This kind of inspection is different from general ones in that inspectors not only need to check each individual food item one by one but also need to conduct the whole process in the freezing -18 degrees Celcius freezer.  Some food operators would even say: "I will not turn off the fan in the cooler, let us see how long you can endure such low temperature.” Hence, inspectors not only have the freezing temperature to worry about. They also need to watch out for their own safety while making sure all the physical and photo evidence are secured. If they find any expired product and if the quantity is huge without complete traceability reports, they must review and verify all the data the operator keeps, such as import/export records, to clarify the facts, which is like looking for a needle in the haystack. For food products without labels, inspectors go through the company’s complete deck of import/export declarations or business warehousing records to determine the food expiration date.

In one of our recent cases, our inspectors worked with the Taichung District Prosecutors Office and searched a food operator’s establishment. Every inspector worked until the middle of the night, staying in the large walk-in freezers during most of the time wearing thick down jackets and gloves. Despite the harsh environment, they were meticulous and thorough, leaving no detail or problematic products behind. Many inspectors’ hands and noses were frozen to unconsciousness, and even suffered frost bites. Worst of all, at the end of the investigation, the staff of the company grumbled about how long the investigation took and how they were kept working and sleepless as a result. However, did anyone sympathize with these hard-working inspectors? All they want to do is to safeguard food safety for everyone, including the consumers and the food business operators.

Everyone in TFDA spares no effort in keeping close tabs on food safety. In spite of complex regulations, limited manpower, and high-risk working environment, all the inspectors are committed to deliver high-quality, rigorous and efficient inspection work. Every time a fraudulent food operator is caught and stopped, it gives all the inspectors the biggest reward and affirmation that their work is meaningful and important. Let’s stand with our inspectors and give them our steadfast support and applause! 

To improve the integrity of the quality of medicinal products, TFDA positively amend the regulation of the Pharmaceutical Affairs Act. The amendment of Article 53-1 of the aforementioned act had been approved by The Legislative Yuan, Republic of China and issued on 14^th June, 2017. The law defines the companies who wholesale, import or export the medicinal products shall comply GDP. TFDA will continue amending related regulations and reaching the consensus of timetable in stage with related association, and then, accomplishes the GDP execution in Taiwan.

The inspectors play an important role in constructing a safety and quality environment of medicinal products to public. The inspectors should have an instinct like detective Holmes with careful and bold mind. Via scrutinized gathering evidences and perseverance, the inspectors will reveal the illegals. This time to reveal

the illegal of Chung-long trading Co. Ltd. and Tien-Liang Biotech Co. Ltd. for tampering the medicine labels and expire date are attributed to the alerts of the inspectors whose skillful skills need many years to cultivate.

TFDA positively ensures the safe environment of using medicine by not only completing related laws and executing inspection, but also holding plenty of training and counseling activities to elevate the professional of industries. By doing so, TFDA can create a third-win situation: public, industry and government, and therefore to improve the well-being of the people.

Taiwan Food and Drug Administration (FDA) prepared the countermeasures of the ever-changing internet threats, such as the immediate repair principle of relevant computer weaknesses, the regular backup of important information, the effective disaster recovery exercise for application systems, and the policy and drill of continuous operational planning for core business. Those efforts reduce security impacts.

Taiwan FDA continuously train all colleagues by using the e-mail of social engineering exercises. All FDA colleagues have the security knowledge.

In addition to making sure that the quality of the food cleansers sold in Taiwan conforms to the statutory requirement; the product name, chemical names of main ingredients, net weight or volume, name, telephone number and address of the responsible domestic company, country of origin, manufacturing date, applicable targets or purpose, method of use, precautions for use or warnings, or other matters designated by the central competent health authority in public announcements must be labeled in Chinese and common symbols in accordance with Article 27 of the Act Governing Food Safety and Sanitation. Pursuant to Article 28 of the same Act, the products shall not be labeled with false, exaggerated, or misleading words or phrases such as "non-toxic" and "food grade". Those labeled with "natural" or "organic" shall indeed contain natural materials or the organic agricultural raw materials approved by the competent agricultural authorities; besides, the proportion, in percentages, of such ingredients must also be indicated on the containers or external packaging of the products from January 1, 2018.

Olive oil is a widely used oil in much of the world according to its pleasant taste and aroma. However, the high price of extra virgin olive oils has led to the widespread adulteration of olive oil. The criteria outlined in “Codex standard for olive oils” (CODEX 2015) (e.g. free acidity) make it difficult to discriminate between refined and unrefined olive oils.

The quality of olive oil is generally based on sensory analysis by skilled tasters; however, this method is highly subjective. As a result, TFDA used 3-monochloropropane-1,2-diol (3-MCPD) esters as target compounds to identify extra virgin olive oils adulterated with refined olive oils by GC-MS/MS.

3-MCPD esters form in olive oil at high temperature, and the process of refining olive oil involves heating; therefore, 3-MCPD esters could be used in the grading of olive oil. In 42 commercial olive oil products, the concentrations of 3-MCPD esters were considerably higher in refined oils (olive oil and olive pomace oil) than those in unrefined (extra virgin) olive oils. Furthermore, the distribution of 3-MCPD esters in refined olive oils is widely dispersed.

TFDA shows the outstanding technology after years of development. The authority will use this novel analytical methods to investigate labeling compliance of the commercial extra virgin olive oils in Taiwan market. TFDA continuously develops new analytical methods for food management to protect the public health.

Edible animal fats, such as lard and tallow, are widely used in pan-frying, stir-frying and deep-frying due to a desirable flavor which differs from that of vegetable oils, particularly in Asian countries. In 2014, a Taiwanese trader was discovered to have added cooked oil to lard in order to reduce production costs. It caused great economic loss to catering industry, affected public health, and highlighted the importance of analytical methods which can reliably identify adulterated animal fats.

Since the oil refining process reduces the values of most common quality indexes in these adulterated animal fats, there are currently no effective methods to discriminate between refined cooked oils and natural edible oils. Phytosterols are sterols in plants, and the contents of major phytosterols are not significantly affected by the oil refining process. Therefore, TFDA established an analytical method by detecting four common phytosterols (campesterol, stigmasterol, β-sitosterol and β-sitostanol) using LC-MS/MS for the determination of adulterated animal fats contaminated with cooked oils.

The phytosterol contents in inspected lard samples from companies that had been found guilty of adulterating lard in 2014 were higher than that found in homemade and commercial lard samples. In these inspected lard samples, the phytosterol contents in crude lard were higher than those in refined lard samples. Findings from this study suggest that phytosterols could be great candidates for the determination of adulterated animal fats.

This method is useful to screen out the animal fats which were most likely adulterated with refined cooked oils and could be used in conjunction with other analytical methods and adulteration inspections to strengthen judgments made in a court of law and to improve the quality of animal fats.

TFDA shows the outstanding technology after years of development. The authority will use this novel analytical method to monitor the crude lards in origins accompany with inspection result to prevent animal fats from adulterating with cooked oils. TFDA continuously develops new analytical methods for food management to protect the public health.

  Although tip-offs are conducive to the investigation of corruption, the identity of informants must be kept confidential in order to protect them, safeguarding the rights and interests of informants and, at the same time, encouraging members of the public to bravely report any corruption by granting rewards.

  With the dedication of government employee ethics officers and the Agency Against Corruption (AAC) in related anti-corruption work and the full support of chief officials, we believe that we can without a doubt accomplish the objective of “Honest Government, Faithful Society, and Clean Homeland”.

The applications of Dutch, Swedish, and Japanese beef imports all had to first undergo documentation review, risk assessment, site inspection, and examination by Bovine spongiform encephalopathy experts in accordance with standard procedures before they were submitted for cross-department examination and approval for subsequent planning. After some discussion, the cross-department council for this case [including the Office of Food Safety (Executive Yuan), Ministry of Economic Affairs, Council of Agriculture (Executive Yuan), and Ministry of Health and Welfare] has decided to make a public announcement in order to solicit opinions from different sectors.

Currently, 94% of the beef in Taiwan is imported, with the import trade open to the following countries: the United States, Canada, Australia, New Zealand and Paraguay. The FDA emphasized once again that as long as the cattle are healthy, the beef and beef products will be safe. Beef imports from the Netherlands, Sweden, and Japan must meet the same conditions as those from the United States and Canada. Healthy cattle must be monitored and inspected following strict standards in the country of export. Once imported, the place of origin must be clearly labeled. For information on the risk assessment for beef products from these three countries, please go to the “beef imports” section of the FDA website (http://www.fda.gov.tw).

The major issues of the amendment are as below:

When necessary, MOHW can contract out making schedule I or II controlled drugs to a third party manufacturer. The amendment authorizes MOHW to set regulations to determine the qualifications and management of the contract manufacturing plant, and to revise the relevant penalties.

Secondly, The TFDA may use the schedule I and II drugs that have not yet been approved by the authorities for medical and scientific research.

Third, in practical terms, the TFDA pre-estimated demand of schedule I and II drugs have to be reported to the MOHW, instead of reporting to the Executive Yuan for approved.

Fourth, with the government reorganization, the authority names have been revised.

After the amendments, the government will have a clear authority by law to commission the private pharmaceutical industry to produce schedule I and II controlled drugs. The government can also regulate  management and security of all manufacturing facilities and products. It is effective and advantageous for controlled drug supply.

PIC/S is an official international organization presently comprises 49 Participating Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products coming from all over the world (Europe, Africa, America, Asia and Australasia). It leads the international development, implementation and maintenance of harmonized GMP standards and quality systems of inspectorates and other international affairs.

TFDA submitted PIC/S membership application in June 2010 and underwent a series of rigorous assessment process, which included dossier assessment and on-site visit. During the assessment, 89 indicators were satisfied by PIC/S, including regulatory directives and policies, quality management system, inspection resources, alert and crisis systems etc. The Pharmaceutical Affair Act had been amended to specify that all pharmaceutical manufacturers engaged in the manufacture of medicinal products in Taiwan must be in compliance with PIC/S GMP. After 2 years and 6 months' efforts, TFDA became PIC/S 43th official participating authority as from 1 January 2013 (6th in Asia-Pacific, ahead of Japan and Korea).

Through PIC/S platform, we could share information with other members, including quality defects of medicinal products by PIC/S Rapid Alert and Recall System, participate inspector training activities and harmonize the inspection procedures and quality system in the field of GMP with international standards, facilitate co-operation and networking with other members, thus increasing the mutual confidence and further to voluntary sharing of GMP reports or recognition of GMP Certificates.

Taiwan Food and Drug Administration (TFDA) is responsible for the prevention aspect of the anti-drug strategy. The core tasks include preventing the illegal import of drug ingredients and strengthening the ability to analyze new drugs. The Ministry of Education, the Ministry of Justice and the Ministry of Health and Welfare are responsible for drug refusal, enforcement and rehabilitation aspects of the strategy respectively. The main tasks include adolescent counseling network, strengthening drug enforcement ability, drug supply blocking, and improving treatment coverage.

 To proclaim government determination and to release the “New Generation Anti-drug Strategy”, TFDA invited non-governmental organization representatives and substance abuse experts to discuss the new strategy at the 2017 National Anti-drug Debriefing on June 3, 2017. Moreover, the Executive Yuan hold several strategy illustration forums to share experience and collect views of local governments.

Facing the problem that people are using drugs at younger age and the appearance of endless new drugs, TFDA calls for the support of the whole population on the anti-drug strategy. We believe with cooperation between government and citizen, the goal of becoming a drug free society can be achieved by the new thinking and active promotion of the “New Generation Anti-drug Strategy”.

In order to tighten up drug management and to stop illegal drugs from entering the market, the Executive Yuan established an inter-departmental taskforce in March 2010, which included the National Police Agency, the Ministry of the Interior, the Ministry of Justice, the Customs Administration and the Ministry of Health and Welfare. The aims were cracking down on illegal drugs, bringing relevant regulations up to date, monitoring drug advertisements and strengthening public health education. According to studies, the percentage of illegal drugs declines gradually from 27.22% in April 2010 to 0.33% in April 2017.

In 2015, TFDA comprehensively reviewed the Pharmaceutical Affairs Act and revised relevant regulations, sharply increasing fines for counterfeit drugs and adding regulations to address unjustified enrichment and confiscation. A traceability system was established to encourage responsible practices by upstream and downstream manufacturers. This system could track information about manufacturing sources faster, and help to ensure the quality of drugs and their components.

TFDA is using additional strategies to prevent counterfeit drugs, including:

1.     Using big-data analysis to implement cross-comparisons with health insurance claims data to trigger early warnings and monitor abnormal signals.

2.     Strengthening inspections and sampling for high-risk projects, and improving the drug traceability system to prevent counterfeit drugs from entering legitimate supply chains.

3. Promoting Good Distributing Practices (GDP) to ensure product quality and safety.

To avoid the hazards of counterfeit drugs, TFDA also promotes drug safety awareness through a range of outreach activities that share information on how to buy safe medical products and how to avoid counterfeit drugs. Websites also provide the public with relevant information on counterfeit drugs and drug safety. TFDA will continue to work with inter-departmental agencies to effectively fight against illegal drugs to achieve the goals of protecting consumer.

1. Partial amendment of expedited review system and new drug review path

Accelerated approval pathway, priority review designation and abbreviated review designation are programs of TFDA which intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

The new qualifying criteria of accelerated approval, priority review and abbreviated review are as follows:

Accelerated Approval (all criteria need to be met)

• New chemical entities, new combination, new indication and new administration route.
• An application for a drug which addresses unmet medical need in the treatment of serious conditions and providing major clinical advance. OR

An application for a drug which addresses unmet medical need with orphan drug designation in advanced countries.

• An application that demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.

Priority Review (meet two of the following criteria)

• New chemical entities, new combination, new indication and new administration route.
• An application for a drug which addresses unmet medical need in the treatment of serious conditions and, if approved, would provide major clinical advance.
• An application for a drug which addresses unmet medical need and is under special national scientific research and development programs.

Abbreviated Review

An application for new chemical entities which fulfills all the following criteria:

• Approval by two of the three regulatory agencies (US FDA, EMA, or MHLW/PMDA) and with bridging study waiver.
• Providing full review reports from two of the three regulatory agencies (US FDA, EMA or MHLW/PMDA).
• Providing Risk Management Plans and updated Post-marketing Commitment reports requested by two of the three regulatory agencies (US FDA, EMA or MHLW/PMDA).

By comparison, the first criterion for accelerated approval pathway and priority review designation was amended from “new chemical entities only” to a broader range as “new chemical entities, new combination, new indication and new administration route”. For abbreviated review designation, the “MHLW/PMDA” was added as one of the reference regulatory agencies.

2. Announcement of review milestones timelines

In order to improve the transparency of review process, TFDA announced detailed review milestones timelines for NDA/BLA as illustrated in Figure 1. This would benefit the preparation of NDA/BLA submission.

3. Refusal to File (RTF) procedures for NDA/BLA and ANDA

RTF is a new policy to facilitate TFDA/CDE processes by avoiding unnecessary review of incomplete applications. It is applicants’ obligation to provide complete packages for TFDA/CDE to initiate appropriate review processes. From 2017, applications which are not prepared in CTD format or without complete administrative or technique documents are subject to RTF decisions.

The RTF procedure is illustrated in Figure 2.

4. New policy of consultation service

Huge investments are required, including time and resource, to develop a new drug. Pre-NDA Meeting, Pre-ANDA Meeting and Module-Based Rolling Review are new consultation services initiated by TFDA/CDE to accelerate and encourage the new drug development in Taiwan. These new fee-charging services are described below:

Pre-NDA Meeting, Pre-ANDA Meeting

Under preparing for new drug application and generic drug application, sponsors might be interested in the basic requirements or TFDA/CDE review processes. The purpose of the Pre-NDA or Pre-ANDA Meeting is to discuss filing and format (CTD format) issues prior to NDA/ANDA submissions. The meeting also addresses issues that may cause refuse-to-file or hinder the review process. TFDA/CDE can also be aware of upcoming applications and equipped with required resources.

Module-Based Rolling Review

Module-Based Rolling Review is another consultation service especially for those cases have been enrolled in TFDA counseling projects and CDE index cases list, which allowing earlier submission and initiation of review. Sponsors can submit completed sections of its NDA or BLA in CTD format for TFDA/CDE’s review, rather than waiting till all sections of the NDA/BLA are completed.

With the aforementioned amendments, the quality and efficiency of drug approval process are expected to be significantly improved and will lead to a better development of new drug industry in Taiwan.

Medical devices are closely related to our lives. From incubators that keep newborn babies warm to contact lenses which are used among the youth, or from first-aid bandages for treating minor cuts to reading glasses used by the elderly, these are all considered to be “medical devices.” To ensure the safety,   effectiveness and quality of medical devices, TFDA categorizes medical devices into three classes according to their risk level: Class I (low risk), Class II (medium risk), and Class III (high risk). At the same time, TFDA regulates medical devices by auditing quality management system of manufacturers, performing pre-market assessment, and conducting post-market surveillance to protect consumers.

“What are the differences between the new Act from the present Act?” The proposed new regulation further implements the classification system of medical devices, since applications of certain kinds of Class I medical devices will be changed to electronic listing and applicants will be required to annually report their devices through an annual declaration system. Moreover, the new Act strengthens the management of medical device manufacturers. In addition to defining medical device manufacturers according to manufacturing phases, legal entities that design and place devices on the market under their names are also incorporated into manufacturers. On the other hand, legal entities that lease medical devices and service or repair medical devices are incorporated into medical device dealers. To keep updated information about devices on the market, manufacturers will have to establish a management mechanism to track medical devices and TFDA will also require Good Distribution Practice (GDP) for medical devices. It is anticipated that the new Act will help improve the medical device regulation into a sound system for life cycle management of medical devices and promote development of the medical device industry. Presently, TFDA has completed the procedures of draft announcement in Taiwan and notification to WTO for collecting comments. It is expected that the draft would be sent to the Executive Yuan for review by the end of 2017.

As the competent authority for regulating medical devices, TFDA will continue to promote various reforms that are globally harmonized, as well as to establish a reasonable and transparent review system and a better regulatory environment. In the meantime, TFDA will also strive to promote relevant biotech industry, enhance international cooperation, and provide consultation assistance related to regulations. It is hoped that these would help industry connect to the world and that medical device industry could become an important force to boost the economic growth, such that Taiwan’s consumers, industry, and government are all benefited. 

The degree of risk, and quality, efficacy and safety of medicines are taken into account to prioritize these three categories of medicines to be implemented with the prescription drug track and trace system.

In addition, due to the counterfeit Crestor event, TFDA has added twenty medicines with top national health insurance reimbursement items as a pilot category to implement the track and trace system. Several public meetings have been held by TFDA to illustrate the track and trace system. It is important to have face-to-face communications with the pharmaceutical companies to reduce difficulty of submission and to improve the willingness of declaration.

The government is continuing to improve the functions of track and trace system with stakeholders. In the future, prescription drug track and trace system will be coordinated with the timetable of implementation of Good Distribution Practice (GDP) to expand the categories. The track and trace system is expected to reduce the possibility of counterfeit medicine distributed into supply chain, and to recall the products efficiently. It is also one of the policies to achieve TFDA’s goal and mission, to secure the public health for all.    

 “Five-point Food Safety Policy,” which connects five focuses from farm to table, covers the “Strengthen source control management,” “Re-establish the food production-management system,” “Strengthen government market inspection capabilities,” “Increase liability for producers and vendors,” and the “Encourage and create oversight platforms”. The implementation objectives of each policy are described below:

1. Strengthen source control management:

The TFDA works to harmonize the regulations and standards and to support the research and development of testing technologies for risk substances in food. Big data analyses are made using a cloud food management system.

2. Re-establish the food production-management system:

The TFDA expands the scope of supervision over a wide array of food businesses and demands the key industries to establish the self-regulatory system, including the food safety monitoring plan, self-testing, and food traceability system, as well as introduction of the food-related professional management mechanism, thereby enabling business owners to enhance their self-regulatory and management systems.

3. Strengthen government inspection capabilities:

The inspection on food items that have a high non-compliance rate, high risk or attract intense consumers attention are performed with increased frequency and intensity based on the principle of “yearly and monthly risk management”. The purpose is to inhibit the bad products enter into the market.

4. Increase liability for producers and vendors:

Laws and regulations are amended to ensure the unscrupulous businesses receive severe penalties. The consolidation of the resources from the prosecution, police and judicial system bolsters the capacity of the public sector to engage in investigations previously limited by the constraints on the executive power of investigation, thereby exposing and destroying unethical practice.

5. Encourage and create oversight platforms:

With the creation of monitoring platforms and facilitation of information disclosure, the TFDA encourages public participation in the general food safety monitoring. The amount of the reward for reporting offences is raised to motivate the civil society to monitor and report unscrupulous practices.

The government, committed to the universal food safety management, implements the “Five-point Food Safety Policy”. Industry self-regulation, government management and civil participation are three major forces behind the effective implementation of the policy to complete the farm-to-table management process as well as to build up a strong and credible food safety system in which the consumers may purchase with confidence. 

Issues of illegal drugs and adulterated dietary supplements are extremely important for human health. The aims of this conference are sharing the knowledge and experiences about regulations, analytical techniques, monitoring systems and mechanisms of illegal drugs and adulterated dietary supplements. On February this year, we proposed to organize and host this conference at the APEC SOM1 SCSC meeting and received widespread support by the APEC national representatives.

To establish a safe medical environment for public, it relies on international cooperation to reduce the distribution of illegal drugs. TFDA invited the experts from the United States, Europe, Japan, Singapore, Korea and Malaysia to share their experiences on the analytical technologies and the management strategies on illegal drugs. Experts from Taiwan, such as Dr. Cheng, Hwei-Fang (Director, Food and Drug Administration), Dr. Shen, Hsin-Pei (Prosecutor, Taipei District Prosecutors Office) and Dr. Liao Wen-I (Officer, Customs Administration), were also invited to share Taiwan’s experience as well. During the conference, Dr. Cheng from TFDA especially delivered thanks to the health authorities, the police station, the courts and the customs for their assistance of inspecting and sampling of high-risk products. She mentioned the illegal drugs grew rapidly in the recent year and were transformed into dietary supplements. For example, sildenafil, sibutramine, amphetamine or new synthetic cathinone drugs were found in dietary supplements and instant coffee or tea bags as well with claim for aphrodisiac, weight loss and stimulant. In addition, illegal nicotine-containing electronic cigarettes were increasing rapidly.

The maintenance of public health and the establishment of a safe medical environment are Government’s responsibility. TFDA expects through this conference to be helpful for preventing illegal usage of medicines and drugs in foods and dietary supplements. Also, this conference can establish a bridge for international cooperation and work hand-in-hand to crackdown on illegal drugs.

The Centers for Disease Control (CDC) reported that the outbreak of influenza in Taiwan earlier last year was more widespread than in previous years. The number of deaths caused by severe illness had reached 431, 1.9 times more than the 147 in the previous year, and was the highest in the last 5 years. In addition to the impact of the massive cold front in late January and the aging population, many believed that the rise of the number of deaths from pneumonia could also be attributed to the influenza epidemic earlier last year. Other potential risk factors for pneumonia led deaths include chronic diseases such as chronic obstructive pulmonary disease, heart disease, asthma, and diabetes.

For the prevention of pneumonia deaths caused by infections, the CDC targeted people belonging to high-risk groups and highly infectious groups for severe illness to implement the annual influenza and streptococcus pneumoniae vaccination program. It also increased the number of publicly-funded influenza vaccines from 3 million doses in previous years to 6 million doses in October last year. The newly added vaccination targets include: high-risk chronic disease patients aged under 50, people with high BMI, women under 6 months postpartum, adults aged between 50 and 64, middle school students, high school and vocational school students, and the first- to third- year students of five-year junior colleges. During the epidemic season, publicly-funded influenza antiviral drugs were given to high-risk groups for severe illnesses, and the targeted groups were expanded depending on the epidemic situation.

To reduce the possible impact of the epidemic, the CDC also specified the principles of distributing and managing publicly-funded influenza antiviral drugs, setting up national distribution points of the publicly-funded drugs, broadening their application targets during the influenza epidemic season, and continuously strengthening the active and passive monitoring system of diseases to control the epidemic situation and ensure public health.

The most effective way to prevent the health hazards of severe illnesses caused by influenza and streptococcus pneumoniae infection is to receive vaccination. The CDC called on the public who are qualified for publicly-funded vaccination to receive regular vaccination at contracted hospitals or medical institutions every year. The MOHW's Advisory Committee on Immunization Practices (ACIP) also recommended that people over 65 years of age who had not been vaccinated against streptococcus pneumoniae should receive vaccination at their own expense to obtain adequate protection. In case pneumonia-like symptoms such as fever, chills, chest pain, cough, shortness of breath and difficulty breathing appear, please be sure to seek medical treatment as soon as possible to avoid the occurrence of severe illness or death. For more information, please visit the website of the CDC (http://www.cdc.gov.tw) or by calling the toll-free epidemic prevention hotline (+866-800-001922).

In 2016, there were 172,418 deaths in Taiwan, an increase of 8,844 deaths or 5.4％ compared to the previous year. The deaths for males and females were 102,985 and 69,433, respectively.

The crude death rate was 733.2 deaths per 100,000 population in 2016, increased by 5.2％ compared to 2015; the age-adjusted death rate(based on the WHO standard world population age structure 2000) was 439.4 deaths per 100,000 population, an increase of 1.8％ over the previous year.

About 70.9％ of all deaths in Taiwan attributed to the population aged 65 and over in 2016. The deaths of the population aged 65 and over were 122,256, increased 7,567 deaths or 6.6％ from 2015.

The 10 leading causes of death in 2016

The 10 leading causes of death for 2016 were, in rank order: (1)Malignant neoplasms(cancers); (2)Diseases of heart; (3)Pneumonia; (4)Cerebrovascular diseases; (5)Diabetes mellitus; (6)Accidents; (7)Chronic lower respiratory diseases; (8)Hypertensive diseases; (9)Nephritis, nephrotic syndrome and nephrosis; and (10)Chronic liver diseases and cirrhosis. They accounted for 76.8％ of all deaths in Taiwan.

Two causes changed rank in 2016 compared to 2015. Pneumonia moved up from the fourth to the third rank, and Cerebrovascular diseases moved down from the third to the fourth rank.

The leading causes of death varied by age group, the top two causes for the population aged 1-14 were Accidents and Cancers; for the population aged 15-24 were Accidents and Suicides; for the population aged 25-44 were Cancers and Accidents; for the population aged 45 and over were Cancers and Diseases of heart.

The 10 leading causes of cancer death in 2016

There were 47,760 deaths due to cancer, which accounted for 27.7％ of total deaths. The crude death rate was 203.1 deaths per 100,000 population, an increase of 1.8％ compared to the previous year；the age-adjusted death rate was 126.8 deaths per 100,000 population, a decrease of 0.9％.

 The 10 leading causes of cancer death in 2016 were (1) Cancers of trachea, bronchus and lung; (2) Cancers of liver and intrahepatic bile ducts; (3) Cancers of colon, rectum and anus (4) Cancer of breast(Female); (5) Cancer of oral cavity; (6) Cancer of prostate; (7) Cancer of stomach; (8) Cancer of pancreas; (9) Cancer of oesophagus; (10) Cancer of ovary. They accounted for 76.6％ of total cancer deaths.

Statistical Tables

Table1. Causes of Death, 2015 and 2016

Table2. Causes of Death for Males, 2015 and 2016

Table3. Causes of Death for Females, 2015 and 2016

Table4. Causes of Cancer Death, 2015 and 2016

Table5. Causes of Cancer Death for Males, 2015 and 2016

Table6. Causes of Cancer Death for Females, 2015 and 2016

For Further Information:

Specify the content of each major long-term care plan, including: home-based, community-based, institutionalized, and integrated cares.
Specify the professional requirements for the long-term care personnel.
Specify the financial resources for long-term care service and establish funds reserved for it, in order to promote the development of long-term care service, enhance the quality and efficiency of the service, and consolidate its human resources.
Employers can request supplementary training for first-time family caregivers from foreign countries.
Include family caregivers into the service.

The LCSA authorizes one set of laws and eight regulations and orders in total: Enforcement Rules for LCSA, Regulations for Accreditation of Long-Term Care Institutions, Regulations for Continuing Education and Registration for Training Certification of Long-Term Care Personnel, Regulations Governing Awards and Grants for Development of Long-Term Care Resources, Establishment Standards for Long-Term Care Institutions, Regulations Governing Permission and Management of Long-Term Care Institutions, Regulations Governing Inspection of Applications for Rental of State-Owned Non-Public Properties by Long-Term Care Institutions, and Regulations Governing Supplementary Training System for Foreign Family Caregivers.

Continued Operation of Existing Long-Term Care Institutions

Although existing nursing homes and charity organizations for senior citizens and the disabled that have been providing community-based or institutional services can continue operating under current laws, the government offers them the option of a simplified application and waives the requirement for another authorization, should any of them plan to transition into a long-term care institution. Existing day-care centers are also included in the beneficiaries of this simplified procedure. Considering the differences between regions, the application and recognition of long-term care institutions in aboriginal regions can follow the more adaptive special-case protocol under the newly enforced act.

In response to concerns previously expressed from various sectors about the Establishment Standards for Long-Term Care Institutions and Regulations Governing Permission and Management of Long-Term Care Institutions, the Ministry of Health and Welfare announced the standard requirements for establishment of a long-term care institution, the standard protocol for its application, and consistent regulations for its subsequent management to serve as references for interested private organizations. Criteria for smaller-scale multifunctional nursing homes were also included.

Protection of Current Care Recipients’ Rights

In the future, all long-term care personnel are required to complete certain training sessions, receive corresponding certificates, and register at long-term care institutions before they can start providing service. In addition, to protect the rights of care recipients, such personnel are required to complete at least 120 points of continuing education every six years. To ensure the quality of care provided by foreign caregivers, employers can judge if there is a need for additional training and request supplementary training for them accordingly.

Enhancing the Overall Development of Community-Based Care Services

To encourage more private organizations to participate, state-owned non-public properties are available for nonprofit or charity organizations engaging in long-term care services to rent at a discounted rate in accordance with the Regulations Governing Inspection of Applications for Rental of State-Owned Non-Public Properties by Long-Term Care Institutions.

Adhering to the principle of equal participation from government and private organizations, the Ministry of Health and Welfare held over a hundred meetings with several local government agencies and private organizations to devise the appropriate procedures and regulations under LCSA. After the regulations were passed following standard procedures as planned, they have become effective starting today (June 3). Director of the Department of Nursing and Health Care Tsai, Shu-feng stated that current long-term care institutions can continue operating as before, only with better protection of the care recipients’ rights and enhancement of the 2.0 community-based long-term care system.

     Working hard to realize President Tsai’s manifestoes, the Ministry of Health and Welfare launched the Accounts for Children and Teenagers’ Future Education and Development Project after nearly one year of planning, in order to assist orphans or children from underprivileged family to realize their dreams. The Ministry co-organized the opening ceremony today with Taiwan Fund for Children and Families; the Child Welfare League Foundation and World Vision also attended the ceremony to show their support. During the ceremony, Minister Chen Shih-chung particularly expressed his gratitude toward the Bank of Taiwan and Chunghwa Post for their assistance with setting up the accounts. He also gave certificates of appreciation to Huaijen Center for Human Becoming, Yonglin Foundation, and Bliss and Wisdom Foundation of Culture and Education for the material assistance they will provide for the future participating families. The short film advertising the Project was shown to the public today for the first time as well. The Ministry invited financially independent teenagers and six participating parents to the ceremony, to share their stories with others and encourage other families with similar needs to join.

The objective of the Accounts for Children and Teenagers Project is to help underprivileged children to save up funds for more and better future opportunities. Collaboration between the government, private organizations, and the families themselves enables the children to set up a personal account, into which their parents can deposit up to NT$15,000 per year, which will then be doubled by the government. Most importantly, the savings in these children’s accounts will not affect the other social benefits received by the family. The government will also work with private organizations to provide other helps in the form of counseling, material supplies, and finance management lessons, in order to maximize these families’ ability to save up for their children.

        The Ministry of Health and Welfare reminds the public that any registered low-income and low-to-medium-income households with children born after January 1, 2016 can submit applications to the social affairs bureaus/departments in their cities/ counties of residence. For more information, please visit the website (https://goo.gl/ZcdKvG) or call the toll-free social welfare hotline 1957 (8 a.m. to 10 p.m. every day).