“Dual-track regulatory”models for regenerative medicine in Japan and the Republic of Korea and their impli-cations for China
- VernacularTitle:日韩再生医学“双轨制”监管模式介绍及对我国的启示
- Author:
Yifan YANG
1
;
Jinping XIE
1
;
Rong SHAO
1
Author Information
1. Institute of Regulatory Science for Medical Products，China Pharmaceutical University，Nanjing 211198，China
- Publication Type:Journal Article
- Keywords:
regenerative medicine;
cell and gene therapy;
dual-track regulatory;
regulatory science;
Japan;
the Republic of
- From:
China Pharmacy
2025;36(15):1832-1836
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provide references and recommendations for improving the regulatory framework for cell and gene therapy products and treatments in China. METHODS This study systematically examined the “dual-track regulatory” frameworks for regenerative medicine products and treatments in Japan and the Republic of Korea， summarized their beneficial experiences， and explored optimization strategies for China’s regulatory practices. RESULTS & CONCLUSIONS Both Japan and the Republic of Korea have established clear management processes for two distinct pathways “registered clinical trials for regenerative medicine products” and “clinical research on regenerative medicine treatments” guided by shared principles of “risk stratification” and “full lifecycle oversight”. Based on these findings， it is recommended that China： strengthen top-tier legislative framework to explicitly delineate the regulatory scope governing cell and gene therapy products and treatments； clarify the jurisdictional responsibilities of relevant regulatory bodies to enhance oversight efficacy； appropriately calibrate the regulatory scope， and adopt a balanced regulatory approach that harmonizes standardization with innovation incentives， thereby accelerating the clinical translation of regenerative medicine products.
