中国药业2026，Vol.35Issue(4)：35-40,6.DOI:10.3969/j.issn.1006-4931.2026.04.006
药品上市许可持有人药物警戒监管创新的浙江台州实践
Zhejiang Taizhou's Practice in Pharmacovigilance Supervision Innovation for Marketing Authorization Holders
摘要
Abstract
Objective To explore the pathways and practical effectiveness of enhancing pharmacovigilance supervision capabilities through digital and intelligent technologies.Methods The current construction status and institutional background of pharmacovigilance supervision models were analyzed,combined with the current situation of pharmacovigilance supervision for marketing authorization holders(MAH)and the requirements for enterprises to fullfill their primary responsibilities,the MAH Pharmacovigilance Online Supervision System implemented in Taizhou,Zhejiang Province was taken as an example.By examining its system architecture,core functional modules,and operational mechanisms,the effectiveness in improving regulatory efficiency,strengthening enterprises' primary responsibilities,and enabling risk early warning were evacuated.Results The efficiency of current MAH pharmacovigilance supervision models in this city are low and the fulfillment of primary responsibitities for pharmacovigilance is insufficient.The practice has reshaped the pharmacovigilance supervision process through digitalization,achieving a transformation in work mode from "human sea tractis" to "data and intelligence-driven",in data governance from "information silos" to "shared and co-governance",and in risk management from "retrospective tracing" to "proactive early warning".Conclusion Digital and intelligent empowerment is a key pathway to enhance MAH pharmacovigilance supervision effectiveness.Through the development of digital systems,the pain points of traditional supervision models can be addressed,promoting the digital transformation of drug regulatory systems.The Taizhou's practice provides replicable and scalable exemplary experience for nationwide implementation,offering a new paradigm for drug safety governance.关键词
药物警戒/药品上市许可持有人/数智赋能/数字化转型Key words
pharmacovigilance/marketing authorization holder/digital and intelligent empowerment/digital transformation分类
医药卫生引用本文复制引用
高小羲,曾茂法..药品上市许可持有人药物警戒监管创新的浙江台州实践[J].中国药业,2026,35(4):35-40,6.基金项目
浙江省药品监督管理局科技计划项目[2024033]. （）
