Compilation Instruction for Pharmacovigilance Guideline for Clinical Application of Chinese Patent Medicine for External Use
10.13422/j.cnki.syfjx.20252296
- VernacularTitle:《外用中成药临床应用药物警戒指南》编制说明
- Author:
Xin CUI
1
;
Dingquan YANG
2
;
Zhennian XIE
3
;
Yuanyuan LI
1
;
Zhifei WANG
1
;
Xu WEI
4
;
Jinghua GAO
4
;
Lianxin WANG
1
;
Yanming XIE
1
Author Information
1. Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences， Beijing 100700，China
2. China-Japanese Friendship Hospital，Beijing 100029，China
3. Xiyuan Hospital，China Academy of Chinese Medical Sciences，Beijing 100091，China
4. Wangjing Hospital，China Academy of Chinese Medical Sciences，Beijing 100102，China
- Publication Type:Journal Article
- Keywords:
external Chinese patent medicines;
pharmacovigilance;
compilation instruction;
guideline;
clinical application
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(8):252-259
- CountryChina
- Language:Chinese
-
Abstract:
The Pharmacovigilance Guideline for Clinical Application of Chinese Patent Medicine for External Use （T/CACM 1563.5—2024）， the first guideline in China specializing for the clinical safety of Chinese patent medicines for external use， was led by the Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，and jointly developed by more than 30 research institutions of medical sciences across the country. Aiming to standardize the pharmacovigilance activities in the clinical application of Chinese patent medicines for external use，the guideline systematically categorizes potential risks and proposes prevention and control measures that cover 11 core sections of risk monitoring and reporting， signal identification，as well as assessment and control， addressing the gap in domestic and international standardization of this field. The compilation of this guideline strictly adhered to international norms and domestic regulations， involving multiple rounds of expert consultations，hybrid interviews， and evidence integration （covering literature，medical insurance，essential medicine，pharmacopoeia data， and regulatory information）. With the scope of application defined to include medical institutions， pharmaceutical manufacturers and distribution enterprises，as well as regulatory authorities， the guideline focuses on key issues such as inherent medicine risks，quality risks，off-label use，risks of combination therapy，and the safety in special populations. During the compilation，core discrepancies such as the definition of application scope and quality risk control were addressed to ensure alignment with regulations such as the Drug Administration Law of the People's Republic of China and the Good Pharmacovigilance Practice. The guideline is registered internationally （PREPARE—2022CN463）. In the future，the implementation of the guideline will be promoted through hierarchical dissemination，dynamic revision，and post-effectiveness evaluation， contributing to rational clinical use and improved patient safety.
