Analysis of the development course and trends of pharmacovigilance in China
- VernacularTitle:我国药物警戒发展历程及趋势分析
- Author:
Hongling LI
1
;
Yurong ZHANG
1
;
Zhengbi QIN
2
;
Mingjie ZHENG
3
;
Li ZHAO
4
Author Information
1. Dept. of Pharmacy，Minda Hospital of Hubei Minzu University，Hubei Enshi 445000，China;Hubei Provincial Key Laboratory of Occurrence and Intervention of Rheumatic Diseases，Minda Hospital of Hubei Minzu University，Hubei Enshi 445000，China;Hubei Provincial Clinical Medical Research Center for Nephropathy，Minda Hospital of Hubei Minzu University，Hubei Enshi 445000，China
2. Medical School，Hubei Minzu University，Hubei Enshi 445000，China
3. Center for Drug Reevaluation，NMPA，Beijing 100076，China
4. Hubei Center for Adverse Drug Reaction/Adverse Drug Event Monitoring，Wuhan 430070，China
- Publication Type:Journal Article
- Keywords:
adverse drug reaction;
whole life cycle of medicinal products;
information-based construction;
development course
- From:
China Pharmacy
2026;37(17):2327-2331
- CountryChina
- Language:Chinese
-
Abstract:
Pharmacovigilance runs through the whole life cycle of drugs. This paper systematically sorts out the development course of pharmacovigilance in China， from the initial establishment of the adverse drug reaction reporting system to the gradual construction of a complete pharmacovigilance system aligned with international standards. It focuses on analyzing the evolutionary features of the organizational system， legal system and monitoring system during this process. On this basis， this paper further discusses the future development trends of pharmacovigilance in China. In general， remarkable progress has been achieved in both regulatory construction and practical implementation of China’s pharmacovigilance system. In the future， efforts should be continuously made to improve the pharmacovigilance system， such as accelerating the implementation of the “one-body with two-wings” working framework and strengthening the primary responsibility of marketing authorization holders. It is also necessary to cultivate and reserve professional talents and promote information-based construction， including optimizing the spontaneous reporting system and establishing active monitoring systems. These measures can provide more solid support for ensuring public drug safety and facilitating high-quality development of the pharmaceutical industry.
