Forty years of construction and innovative development of scientific regulation system of traditional Chinese medicine in China.
10.19540/j.cnki.cjcmm.20250416.601
- Author:
Jun-Ning ZHAO
1
;
Zhi-Shu TANG
2
;
Hua HUA
3
;
Rong SHAO
4
;
Jiang-Yong YU
5
;
Chang-Ming YANG
6
;
Shuang-Fei CAI
7
;
Quan-Mei SUN
7
;
Dong-Ying LI
8
Author Information
1. Key Laboratory of Biological Evaluation of TCM Quality of the State Administration of Traditional Chinese Medicine,Translational Chinese Medicine Key Laboratory of Sichuan Province, Sichuan Translational Medicine Center of Chinese Medicine Chengdu 610041, China Laboratory for Biomedical Effects of Nanomaterials and Nanosafety, Chinese Academy of Sciences, National Center for Nanoscience and Technology Beijing 100190, China.
2. Beijing University of Chinese Medicine Beijing 100029, China.
3. Key Laboratory of Biological Evaluation of TCM Quality of the State Administration of Traditional Chinese Medicine,Translational Chinese Medicine Key Laboratory of Sichuan Province, Sichuan Translational Medicine Center of Chinese Medicine Chengdu 610041, China.
4. China Pharmaceutical University Nanjing 210009, China.
5. Department of Drug Registration (Department of Regulation of Traditional Chinese Medicine and Ethnic Minority Medicine), National Medical Products Administration Beijing 100037, China.
6. Center for Drug Evaluation, National Medical Products Administration Beijing 100076, China.
7. Laboratory for Biomedical Effects of Nanomaterials and Nanosafety, Chinese Academy of Sciences, National Center for Nanoscience and Technology Beijing 100190, China.
8. Institute of Executive Development,National Medical Products Administration Beijing 100073, China.
- Publication Type:Journal Article
- Keywords:
Law of the People′s Republic of China on Traditional Chinese Medicine;
Pharmaceutical Administration Law of the People′s Republic of China;
TCM regulation science;
excellent TCM regulation system;
inheritance and innovation of TCM;
legislation on TCM regulation;
regulation and administration of traditional Chinese medicine(TCM)
- MeSH:
Humans;
China;
Drugs, Chinese Herbal/standards*;
History, 20th Century;
History, 21st Century;
Medicine, Chinese Traditional/trends*
- From:
China Journal of Chinese Materia Medica
2025;50(13):3489-3505
- CountryChina
- Language:Chinese
-
Abstract:
Since the promulgation of the first Drug Administration Law of the People's Republic of China 40 years ago in 1984, China has undergone four main stages in the traditional Chinese medicine(TCM) regulation: the initial establishment of TCM regulation rules(1984-1997), the formation of a modern TCM regulatory system(1998-2014), the reform of the review and approval system for new TCM drugs(2015-2018), and the construction of a scientific regulation system for TCM(2019-2024). Over the past five years, a series of milestone achievements of TCM regulation in China have been achieved in the six aspects, including its strategic objectives and the establishment of a science-based regulatory system, the reform of the review and approval system for new TCM drugs, the optimization and improvement of the TCM standard system and its formation mechanism, comprehensive enhancement of regulatory capabilities for TCM safety, international harmonization of TCM regulation and its role in promoting innovation. Looking ahead, centered on advancing TCMRS to establish a sound regulatory framework tailored to the unique characteristics of TCM, TCM regulation will evolve into new reform patterns, advancing and extending across eight critical fronts, including the legal framework and policy architecture, the review and approval system for new TCM drugs, the quality standard and management system of TCM, the comprehensive quality & safety regulation and traceability system, the research and transformation system for TCMRS, AI-driven innovations in TCM regulation, the coordination between high-quality industrial development and high-level regulation, and the leadership in international cooperation and regulatory harmonization. In this way, a unique path for the development of modern TCM regulation with Chinese characteristics will be pioneered.
