Compilation Instruction and Key Point Interpretation for Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance System in Medical Institutions
10.13422/j.cnki.syfjx.20260697
- VernacularTitle:《医疗机构中药药物警戒体系建设指南》编制说明与关键内容
- Author:
Shuoshuo WEI
1
;
Fumei LIU
1
;
Li ZHANG
2
;
Yuanyuan LI
1
;
Zhifei WANG
1
;
Xiaoxiao ZHAO
1
;
Xin CUI
1
;
Ruili WEI
1
;
Shuo YANG
1
;
Yanming XIE
1
;
Lianxin WANG
1
Author Information
1. Institute of Basic Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China
2. Dongfang Hospital，Beijing University of Chinese Medicine，Beijing 100078，China
- Publication Type:Journal Article
- Keywords:
medical institution;
traditional Chinese medicine pharmacovigilance;
system construction;
guideline;
compilation instruction
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(8):229-237
- CountryChina
- Language:Chinese
-
Abstract:
The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions （T/CACM 1563.2-2024） were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine （TCM）. This guideline was jointly developed with 23 authoritative medical and research institutions in China， under the lead of the Institute of Basic Clinical Medicine， China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM （including research and development， marketing， and application） and to establish a four-dimensional framework of "organizational structure， institutional system， information platform， and vigilance activities". Key components included the establishment of a TCM Safety Committee， the construction of nine core systems， the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use （ICH） E2B standards， alongside the risk monitoring， identification， assessment， and control during clinical trials and post-marketing phases. Therefore， this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations， the guideline compilation involved multiple rounds of expert interviews， systematic evidence integration， and broad consensus. This guideline was specified to be applicable to medical institutions at all levels， primarily addressing core issues， including the difficulty in adverse reaction identification， low reporting rates， and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous， ensuring alignment with current national laws and regulations， and was registered internationally. In the future， implementation will be promoted through standardized training， tiered dissemination， as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks， ensure patient medication safety， and promote the high-quality development of TCM.
