BIO Asia–Taiwan 2021 亞洲生技大會

BIO Asia–Taiwan 2021 亞洲生技大會


Ming-Hsun Liu

Session 11 – Advances in Cell & Gene Therapies

Date:23 July (Friday)
Time:  10:40 – 12:10 (GMT+8)

Kevin, Ming-Hsun Liu

Chief Executive Officer
Center For Drug Evaluation, Taiwan

Mr. Liu was previously the Director of Medicinal Products at Taiwan FDA, providing leadership for the implementation of pharmaceutical regulatory affairs. Before joining TFDA, he held positions as Director at MOHW’s Office of Public Relations, Senior Technical Specialist at MOHW’s Department of Medical Affairs and Section Chief at Centers for Disease Control. Mr. Liu has experience working on public health policy and in the pharmaceutical sector for over two decades.
Mr. Liu received his Bachelor degree in Pharmacy from Kaohsiung Medical University, and he has a Master degree in Pharmacy and Health Sciences from Long Island University.

Speech title & Synopsis

Accelerate the Cell & Gene Therapy-Regulatory Perspective

There has been a significant regulatory innovation regarding regenerative medicinal products in Taiwan since September 2018. Currently the regulatory pathway for regenerative therapy medicinal products is a dual-track system. Cell therapies can be performed via two regulatory pathways by their risk status and future purposes, the objective is to cover urgent patient need and product development at the same time.

One track is for medicinal products, the scope includes cell, gene and tissue engineering therapy. The purpose is to ensure product development. The regulatory authority for this track is Taiwan Food and Drug Administration (TFDA).

Another track is for medical technology, mainly covering autologous cell therapy. It’s based on medical care act and its extended part called the “The Regulation Governing the Application of Specific Medical Examination Technique and Medical Device”. The regulatory authority for this track is the department of medical affairs in the Ministry of Health and Welfare (MOHW).

The dual track system can mitigate the gap of medical products and technique. It will provide the service for those patients with unmet medical needs and at the same time be beneficial for industries to shorten the incubation period of a breakthrough innovation. The dual track system is still evolving to further facilitate the cell and gene therapy development.