Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
10.13422/j.cnki.syfjx.20260296
- VernacularTitle:《口服中成药临床应用药物警戒指南》编制说明
- Author:
Hongyan ZHANG
1
;
Zhifei WANG
1
;
Shuo YANG
1
;
Ruili WEI
1
;
Wenqian PENG
1
;
Yuanyuan LI
1
;
Xin CUI
1
;
Xiaoxiao ZHAO
1
;
Fumei LIU
1
;
Mengmeng WANG
1
;
Yanming XIE
1
;
Lianxin WANG
1
Author Information
1. Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences，Beijing 100700，China
- Publication Type:Journal Article
- Keywords:
oral Chinese patent medicines;
clinical application;
pharmacovigilance;
guidelines;
formulation instructions
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(8):245-251
- CountryChina
- Language:Chinese
-
Abstract:
To standardize the clinical application of oral Chinese patent medicines （CPMs）， and address the safety issues arising from their dosage form characteristics， irrational clinical use， and the lack of targeted pharmacovigilance systems， the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines， aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China （2019 revision）， the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， led a drafting group comprising 18 institutions. After multiple rounds of expert interviews， literature retrieval， evidence screening， and extensive solicitation of opinions， the Guidelines were registered internationally. Systematic standardization focused on safety monitoring， risk identification， assessment， control， and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring， known risks， and potential risks， compared to non-oral CPMs. Then， risk control measures were proposed， including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs， the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine （TCM）， which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions， pharmaceutical manufacturers， and regulatory authorities.
