To promote regulatory convergence across the Asia-Pacific region and enhance the quality and efficiency of drug registration management and medical device regulatory science, the Taiwan FDA organized the 2026 APEC Medical Devices (MD) & Good Registration Management (GRM) Regulatory Science Center of Excellence (CoE) Workshop from August 26 to 28.

This year’s workshop was endorsed by the APEC Regulatory Harmonization Steering Committee (RHSC) as an official training program. The MD session invited industry, academia, and regulatory experts from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the Japan Medical Imaging and Radiological Systems Industries Association (JIRA), Taiwan’s Center for Drug Evaluation (CDE), and TFDA. A total of 76 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.

The GRM session brought together 18 experts from regulatory agencies, academia, and industry, including the European Medicines Agency (EMA), Japan’s PMDA, the D.K. Kim International Center for Regulatory Science at the University of Southern California (USC), TFDA, the Asia Partnership Conference of Pharmaceutical Associations (APAC), and the International Research-Based Pharmaceutical Manufacturers Association (IRPMA). Focusing on key topics such as review strategies for generic drugs, the in-person training is expected to cultivate nearly 60 seed instructors across the regulatory, industry, and academic sectors from 7 APEC member economies. By sharing Good Registration Management standards and best practices, the workshop aims to foster Asia-Pacific regional collaboration and enhance the overall quality and efficiency of medicinal product dossier submissions and reviews through active participant interactions.

This time the workshop combined two work areas of MD and GRM to jointly organize a dedicated session on combination products. International experts were invited to share the latest regulatory trends and review practices, fostering cross-disciplinary exchange and experience sharing to strengthen regulatory science collaboration and regulatory resilience. This year’s training participants came from 17 economies, including Chile, Indonesia, Malaysia, Mexico, Peru, the Philippines, Russia, Singapore, Thailand, Vietnam, Botswana, Costa Rica, Egypt, India, Kyrgyzstan, Nigeria, and Tanzania, fully demonstrating 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.