中国食品药品监管Issue(5)：126-133,8.DOI:10.3969/j.issn.1673-5390.2025.05.013
江西省药品上市许可持有人药物警戒实践挑战及破解策略
Challenges and Solutions for Pharmacovigilance Practices of Drug Marketing Authorization Holders in Jiangxi Province
摘要
Abstract
Objective:This study aims to analyze the implementation of Good Pharmacovigilance Practice(GVP)by drug marketing authorization holders(MAHs)in Jiangxi Province and identify existing challenges,providing references for advancing pharmacovigilance efforts.Methods:The pharmacovigilance inspection results from 2022 to 2024 in Jiangxi Province were analyzed to identify key issues and root causes affecting MAH pharmacovigilance practices.Results:Although all 46 inspected MAHs met GVP requirements,several issues remain.These include a generally passive approach to pharmacovigilance,underdeveloped system infrastructure,insufficient risk management capabilities,and weak interdepartmental collaboration.Conclusion:MAHs should shift their mindset,strengthen their pharmacovigilance system,cultivate specialized personnel,strengthen internal and external cooperation,and fulfill their legal and social responsibilities.Regulatory authorities should improve relevant laws and regulations,develop practical guidance documents,train high-level inspectors,and continuously enhance regulatory capability.关键词
药品上市许可持有人/药物警戒/检查/风险/监管Key words
drug marketing authorization holders/pharmacovigilance/inspection/risk/supervision分类
药学引用本文复制引用
张永知,李穗,吴海波,毛靖峰..江西省药品上市许可持有人药物警戒实践挑战及破解策略[J].中国食品药品监管,2025,(5):126-133,8.基金项目
江西省药品监督管理局科研项目(2024GL23) （2024GL23）
