Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
10.3969/j.issn.1006-2157.2025.04.001
- VernacularTitle:“三结合”注册审评证据体系的定位及“人用经验”价值取向的专家共识
- Author:
Qi WANG
1
;
Yongyan WANG
2
;
Wei XIAO
3
;
Jinzhou TIAN
4
;
Shilin CHEN
5
;
Liguo ZHU
6
;
Guangrong SUN
1
;
Daning ZHANG
7
;
Daihan ZHOU
8
;
Guoqiang MEI
9
;
Baofan SHEN
10
;
Qingguo WANG
1
;
Xixing WANG
11
;
Zheng NAN
12
;
Mingxiang HAN
13
;
Yue GAO
14
;
Xiaohe XIAO
15
;
Xiaobo SUN
16
;
Kaiwen HU
17
;
Liqun JIA
18
;
Li FENG
19
;
Chengyu WU
20
;
Xia DING
1
Author Information
1. Beijing University of Chinese Medicine
2. China Academy of Chinese Medical Sciences
3. Jiangsu Kanion Pharmaceutical Co. , Ltd
4. Dongzhimen Hospital, Beijing University of Chinese Medicine
5. Institute of Herbgenomics, Chengdu University of Traditional Chinese Medicine
6. Wangjing Hospital, China Academy of Chinese Medical Sciences
7. Tianjin Academy of Traditional Chinese Medicine
8. Guangzhou University of Chinese Medicine
9. Hubei University of Chinese Medicine
10. Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
11. Shanxi Traditional Chinese Medical Hospital
12. Affiliated Hospital of Changchun University of Chinese Medicine
13. The First Affiliated Hospital of Anhui University of Chinese Medicine
14. Institute of Military Medicine, Academy of Military Sciences, Chinese People of Liberation Army
15. The Fifth Medical Center of Chinese PLA General Hospital
16. Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences
17. Dongfang Hospital, Beijing University of Chinese Medicine
18. China-Japan Friendship Hospital
19. National Cancer Center
20. Nanjing University of Chinese Medicine
- Publication Type:Journal Article
- Keywords:
Three-in-One;
personal experience;
clinical trials;
expert consensus
- From:
Journal of Beijing University of Traditional Chinese Medicine
2025;48(4):445-450
- CountryChina
- Language:Chinese
-
Abstract:
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
- Full text:2025102816011062829Expert consensus on the positioning of the _Three-in-One_ Registration and Evaluation Evidence System and the value of orientation of the _personal experience_.pdf
