Thoughts and practices on research and development of new traditional Chinese medicine drugs under "three combined" evaluation evidence system.
10.19540/j.cnki.cjcmm.20250124.602
- Author:
Yu-Qiao LU
1
;
Yao LU
1
;
Geng LI
2
;
Tang-You MAO
1
;
Ji-Hua GUO
3
;
Yong ZHU
3
;
Xue WANG
4
;
Xiao-Xiao ZHANG
3
Author Information
1. Dongfang Hospital, Beijing University of Chinese Medicine Beijing 100078, China.
2. Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China.
3. China Association of Chinese Medicine Beijing 100029, China.
4. Chengdu Integrated TCM & Western Medicine Hospital Chengdu 610041, China.
- Publication Type:Journal Article
- Keywords:
"three-combined" evaluation evidence system;
human use experience;
research and development(R&D) of new TCM drugs
- MeSH:
Drugs, Chinese Herbal/standards*;
Humans;
Medicine, Chinese Traditional/standards*;
China;
Drug Development
- From:
China Journal of Chinese Materia Medica
2025;50(7):1994-2000
- CountryChina
- Language:Chinese
-
Abstract:
In recent years, the reform of the registration, evaluation, and approval system for traditional Chinese medicine(TCM) has been promoted at the national level, with establishment of an evaluation evidence system for TCM registration that combines TCM theory, human use experience, and clinical trials(known as the "three-combined" evaluation evidence system). This system, which aligns with the characteristics of TCM clinical practice and the laws of TCM research and development, recognizes the unique value of human use experience in medicine and returns to the essence of medicine as an applied science, thus receiving widespread recognition from both academia and industry. However, it meanwhile poses new and higher challenges. This article delves into the value and challenges faced by the "three-combined" evaluation evidence system from three perspectives: registration management, medical institutions, and the TCM industry. Furthermore, it discusses how the China Association of Chinese Medicine, leveraging its academic platform advantages and leading roles, has made exploratory and practical efforts to facilitate the research and development of new TCM drugs and the implementation of the "three-combined" evaluation evidence system.
