歐盟為加強(qiáng)對(duì)特定藥品不良反應(yīng)的監(jiān)測(cè)力度，及時(shí)收集用藥信息，引入了藥品上市后額外監(jiān)測(cè)制度。該制度鼓勵(lì)醫(yī)務(wù)人員和患者自發(fā)報(bào)告可疑的不良反應(yīng)，以便對(duì)藥品進(jìn)行安全性評(píng)估。介紹了歐盟額外監(jiān)測(cè)制度的管理程序、監(jiān)測(cè)方式以及實(shí)施現(xiàn)狀，并結(jié)合中國(guó)不良反應(yīng)監(jiān)測(cè)制度實(shí)踐情況，借鑒歐盟積累的經(jīng)驗(yàn)，從完善法律體系和上報(bào)系統(tǒng)、制定額外監(jiān)測(cè)藥品納入原則與目錄、加強(qiáng)宣傳等方面構(gòu)建額外監(jiān)測(cè)制度框架，為豐富我國(guó)藥品上市后監(jiān)測(cè)模式，完善藥物警戒體系提供參考。

In order to strengthen the specific adverse drug reactions monitoring and collect medication information timely, the European Union (EU) has introduced the additional monitoring system, which encourages health care professionals and patients to report suspected adverse reactions spontaneously and evaluates the safety of drugs. In this paper, we introduced the management process on monitoring methods and implementation status of the additional monitoring system in EU. Then, we draw lessons from EU on their accumulated experience in additional monitoring from improving the regulation policy and reporting system, establishing the principles and list of additional monitoring drugs, and strengthening publicity, to provide reference for enriching China's post-authorization drug monitoring system and improving the pharmacovigilance 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）