Biomedical technologies are arguably the fastest-growing and most influential arena of innovation, bearing as they do the greatest implications for widespread impacts on human life. As the Executive Yuan has heavily promoted biomedical industry innovation since 2016, our efforts in this area include several initiatives listed below.
- Regenerative Medicine
The 2015 Immune Cell Therapy proposals became law in December when this legislation passed with the support of more than 5,000 citizens. The MOHW has since sought to optimize the regulatory environment for regenerative medicine. After analyzing the existing rules, the MOHW resolved that domestic cell therapy management will be categorized into medical practice and medicinal products. These two tracks will cooperate to promote future guidelines and laws.
Revised regulations on medical devices and techniques were released in September 2018 with a new section on cell therapy techniques. Low-risk cell therapies already proven safe will be permitted under these regulations. The revision specifies how hospitals may offer cell therapy medical techniques to patients with specific indications, and sets standards on cell processing units and staff qualifications. All hospitals offering approved cell therapies must report all cases to the MOHW annually.
- Clinical Trials
Taiwan's excellent clinical trial infrastructure is recognized worldwide. TFDA has accepted applications for cell therapy clinical trials since 2010 and has approved 43 of these. Many trials are phase I safety studies (47%), followed by phase I/II trials for efficacy confirmation (30%) and Phase II trials (19%). These treatments target cancer as well as cardiovascular and osteoarticular diseases. The cell resources originated from autologous (72%), with cell types mainly mesenchymal stem cells (40%), including fat cells, bone marrow cells and cord blood cells. Endothelial precursor cells and immune cells (including T cells, NK cells and dendritic cells) each had a 19% share of the total. It is expected that clinical trials of these cell therapies can benefit patients in the future.
- Precision Medicine
During the successful implementation of the Flagship Program on Precision Medicine we networked with Taiwan Foundation for Rare Diseases and the Taiwan Human Genetics Society to form the Taiwan Rare Disease Network. For the past two years we have offered whole-genome sequencing to more than 100 families affected with rare or undiagnosed diseases such as epilepsy and dementia. Our pilot study provided genetic diagnoses for nearly 60% of such cases. The benefits of these definitive diagnoses include: (1) optimized medication; (2) improved clinical management; (3) prenatal diagnoses; (4) counseling at reproductive clinics; (5) understanding disease pathogenesis; and (6) facilitating drug development.
- Medical and Health Industry Marketing Strategy
Marketing efforts include establishment of the Taiwan Healthcare+ international marketing alliance portal platform and promotion of a related international exhibition. This establishes an international platform with integrated virtual and physical paths whose on-line and off-line fusion mode accelerates Taiwan firms' global market entry (including New Southbound Policy target markets) and builds overseas bases for international marketing promotion.
This platform conducted active matching or order transfers for 123 international cooperation demands from various countries, including 82 from New Southbound countries. Taiwan Healthcare+ Expos have been held to expand and link medical and health industries in the Asia-Pacific and New Southbound regions. These expositions promote interdisciplinary interactions between various experts as well as enhancing cooperation between domestic and foreign clinicians and firms.