Interpretation of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
10.13422/j.cnki.syfjx.20260496
- VernacularTitle:《口服中成药临床应用药物警戒指南》解读
- Author:
Wenxi PENG
1
;
Meng QIAO
1
;
Lianxin WANG
1
;
Yuanyuan LI
1
;
Xiuhui LI
2
;
Xin CUI
1
;
Zijia CHEN
3
;
Xinyi CHEN
1
;
Yi DENG
1
;
Yanming XIE
1
;
Zhifei WANG
1
Author Information
1. Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China
2. Beijing You'an Hospital，Capital Medical University，Beijing 100069，China
3. Xiyuan Hospital，China Academy of Chinese Medical Science，Beijing 100091，China
- Publication Type:Journal Article
- Keywords:
oral Chinese patent medicine;
clinical application;
pharmacovigilance;
interpretation of guidelines
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(6):152-160
- CountryChina
- Language:Chinese
-
Abstract:
The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines （hereinafter referred to as the Guidelines） is first specialized in the field of drug safety for oral Chinese patent medicines （OCPMs） in China. Rooted in China's healthcare context， the Guidelines address the unique usage patterns and risk characteristics of OCPMs， filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines， and to promote the standardized development of pharmacovigilance practices for OCPMs， this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting， the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment， the Guidelines were examined from three dimensions of formulation components， medication behaviors， and population to address complex safety issues arising from medicinal constituents， irrational use， and individual susceptibility. In the area of risk control， the analysis focused on context-based interventions and dynamic closed-loop management strategies， exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore， this paper evaluated the applied value of the Guidelines and identified implementation challenges， such as insufficient capacity at the primary-care level and limited digital infrastructure. In response， the study proposed optimization strategies including establishing a dynamic updating mechanism， strengthening training at the grassroots level， and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders （including manufacturers）， pharmaceutical distributors， healthcare institutions， and research organizations， ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.
