Dr. Chih-Kang Chiang, MD., Ph.D.
Director-General
Taiwan Food and Drug Administration
Ministry of Health and Welfare
Taiwan

Due to rapid development of biotechnology in recent years, the field of regenerative medicine has attracted considerable attention. Regenerative medicine related regulations have been established in several countries to ensure the quality, safety and efficacy of innovative treatments. Considering the diversity of regenerative medicine, the regulatory framework in Taiwan have been adjusted in response to global trend and local demand. Before 2010, cell and gene therapies were regarded as “new medical practice” under the “Medical Care Act”. Along with the establishment of Taiwan Food and Drug Administration (TFDA) in 2010, regenerative medicine was regulated as “medicinal products” under the “Pharmaceutical Affairs Act”. Then, the Ministry of Health and Welfare (MOHW) established a new dual-track regulatory pathway for regenerative medicine in 2016.

The dual-track pathway divided regenerative medicine into medical practices and medicinal products, aiming to improve the accessibility of new treatments to patients and maintain the flexibility for clinical operations. In order to refine the regulation, the MOHW proposed two draft Acts for regenerative medicine in 2022. On June 4th 2024, the Taiwan Legislative Yuan passed the “Regenerative Medicine Act” and the “Regenerative Medicinal Products Act”, and the Taiwan Executive Yuan announce both of the Act enforce On January 1 2026. It is expected that the research and development of regenerative medicine can be further accelerated, thus providing early access to innovative therapies for patients in the future.

Dr. Chih-Kang Chiang, MD., Ph.D.

Director-General
Taiwan Food and Drug Administration
Ministry of Health and Welfare
Taiwan

Dr. Chih-Kang Chiang is the Director-General of the Taiwan Food and Drug Administration (TFDA). Dr. Chiang has a multidisciplinary background bridging clinical medicine, toxicology, and law to advance public health and safety. In addition to his leadership at the TFDA, Dr. Chiang serves as the Attending Director of the Hemodialysis Division at National Taiwan University (NTU) Hospital and as a Professor and Director of NTU’s Graduate Institute of Toxicology. and Deputy Vice President of Academic Affairs.

Dr. Chiang holds an M.D. from Chung Shang Medical University, a Ph.D. in Toxicology and an M.S. in Clinical Medicine from NTU, and an M.S. in Law from National Chengchi University