Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
10.13422/j.cnki.syfjx.20260197
- VernacularTitle:《中药注射剂临床应用药物警戒指南》编制说明
- Author:
Changkuan FU
1
;
Lianxin WANG
1
;
Yihuai ZOU
2
;
Mingquan LI
3
;
Yaming LIN
4
;
Weihong SUN
5
;
Xu WEI
6
;
Ming CHEN
1
;
Yanming XIE
1
;
Yuanyuan LI
1
Author Information
1. Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China
2. Dongzhimen Hospital，Beijing University of Chinese Medicine，Beijing 100700，China
3. The Third Affiliated Hospital of Changchun University of Chinese Medicine，Changchun 130117，China
4. Yunnan Provincial Hospital of Traditional Chinese Medicine，Kunming 650021，China
5. General Hospital of Ningxia Medical University，Yinchuan 750004，China
6. Wangjing Hospital，China Academy of Chinese Medical Sciences，Beijing 100102，China
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine injection;
Chinese patent medicine;
pharmacovigilance;
guideline;
compilation instruction
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(8):238-244
- CountryChina
- Language:Chinese
-
Abstract:
The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections （hereinafter referred to as the Guidelines） were released by the China Association of Chinese Medicine， with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections （TCMIs）. The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， along with 30 experts in TCM pharmacovigilance， clinical practice （TCM， as well as integrated traditional Chinese and Western medicine），and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field， both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1： Rules for the structure and drafting of standardizing documents， the WHO Handbook for Guideline Development，and other methodological norms. Based on international norms，national laws and regulations，and scientific research results in the field of pharmacovigilance， methods adopted included expert interviews，literature research，nominal group technique， and Delphi method. Then， key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring"，"identification"，"assessment"，and "control". The development process of the Guidelines included project initiation， international registration， expert interviews， literature search， and evaluation. Based on the research results of these steps，a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback， the final version was formed. The Guidelines came into effect on January 8，2024，providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process，this study elucidates the background，methodological framework，and key development steps of the Guidelines.
