Interpretation and Implementation Paths of Specification for Quality Control in Traditional Chinese Medicine Clinical Trials
10.13288/j.11-2166/r.2026.20.005
- VernacularTitle:《中医药临床研究质量控制规范》解读与实施路径探讨
- Author:
Haoling ZHANG
1
;
Yanling GAO
2
;
Guanhua REN
3
;
Panbo QIU
4
;
Yiming WANG
1
;
Qingna LI
4
;
Zhenzhen QIAN
5
;
Guoyuan ZHANG
1
;
Xinyue DAI
6
;
Leping WANG
7
;
Rui GAO
4
Author Information
1. Postdoctoral Research Station，China Academy of Chinese Medical Sciences，Beijing，100700
2. National Center of Standards Evaluation
3. China National Institute of Standardization
4. Xiyuan Hospital，China Academy of Chinese Medical Sciences
5. Beijing Tongrentang （Group） Co.，Ltd.
6. China Resources Sanjiu Medical & Pharmaceutical Co.，Ltd.
7. Hunan Chunbo Wanxiang Technology Co.，Ltd.
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine clinical research;
quality control;
standard interpretation;
standardization
- From:
Journal of Traditional Chinese Medicine
2026;67(20):2173-2178
- CountryChina
- Language:Chinese
-
Abstract:
Specification for Quality Control in Traditional Chinese Medicine Clinical Trials（GB/T 47336-2026） is the first national standard in the field of clinical research on traditional Chinese medicine （TCM）， aims to address the core issue that the quality shortcomings of current TCM clinical research restrict the transformation of achievements and international recognition. Through the interpretation of the core contents of this standard， including its scope of application， graded quality control system， TCM-specific quality control requirements， implementation and responsible entities， responsibilities of quality control personnel， formulation of quality control plans， critical nodes of quality control， and quality control archive management， it is believed that the promotion and implementation of this standard are of great significance for improving the standard system of TCM clinical research， enhancing research quality， optimizing the quality management model， and promoting the internationalization process of TCM. Meanwhile， the implementation paths for the standard are discussed， including carrying out pilot applications in institutions， establishing publicity， implementation， and training mechanisms， encouraging multi-party collaborative supervision， and setting up implementation feedback mechanisms. On this basis， the challenges that may be encountered during implementation， such as resource input pressure， difficulties in implementing TCM-specific quality control， and a relative shortage of interdisciplinary composite talents， are sorted out， and corresponding strategies are proposed， which can provide references for relevant researchers and practitioners.
