藥品上市后有效性研究旨在探索藥品在真實(shí)臨床環(huán)境應(yīng)用中產(chǎn)生的實(shí)際效益，是藥品全生命周期監(jiān)管的重要環(huán)節(jié)。歐洲藥品管理局（European Medicines Agency，EMA）經(jīng)過多年的探索和改革，構(gòu)建了較成熟的上市后有效性研究監(jiān)管體系和完善的組織結(jié)構(gòu)，并將其納入了藥品風(fēng)險(xiǎn)管理計(jì)劃，作為上市許可授權(quán)的考量。主要對(duì)EMA的上市后有效性研究管理體系進(jìn)行系統(tǒng)介紹與分析，并結(jié)合中國(guó)藥品上市后有效性研究現(xiàn)狀，從法律法規(guī)建設(shè)、管理體系的完善和指南文件制定方面提出建議，以期推進(jìn)我國(guó)藥品管理體系的完善。

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.

R951

國(guó)家中醫(yī)藥管理局中醫(yī)藥行業(yè)科研專項(xiàng)（201507004）；國(guó)家食品藥品監(jiān)督管理總局保健食品審評(píng)中心保健食品原料目錄研究專項(xiàng)課題（ZBW-2017-BJSP-10）