欧盟药品上市后有效性研究管理制度简介

Introduction of post-authorisation efficacy study management system in European Union

药品上市后有效性研究旨在探索药品在真实临床环境应用中产生的实际效益,是药品全生命周期监管的重要环节。欧洲药品管理局(European Medicines Agency,EMA)经过多年的探索和改革,构建了较成熟的上市后有效性研究监管体系和完善的组织结构,并将其纳入了药品风险管理计划,作为上市许可授权的考量。主要对EMA的上市后有效性研究管理体系进行系统介绍与分析,并结合中国药品上市后有效性研究现状,从法律法规建设、管理体系的完善和指南文件制定方面提出建议,以期推进我国药品管理体系的完善。

The post-authorisation efficacy study(PAES),conducted to collect the benefit data from medical products when used in the real world situation,is important in the life circle of drug administration.After years of exploration,the European Medicine Agency(EMA)has established a fully-fledged structure and an effective regulation network ensuring PAES to be conducted legally and successfully.Moreover,it is required that the PEAS should be drawn up in risk management plan,which will be considered as a condition to be authorized.In this paper,we systematically introduced and analyzed the regulation network system of PAES in EMA,and several policy suggestions based on current policy situation of China to promote the improvement of China’s drug management system.