歐盟為加強對特定藥品不良反應(yīng)的監(jiān)測力度，及時收集用藥信息，引入了藥品上市后額外監(jiān)測制度。該制度鼓勵醫(yī)務(wù)人員和患者自發(fā)報告可疑的不良反應(yīng)，以便對藥品進行安全性評估。介紹了歐盟額外監(jiān)測制度的管理程序、監(jiān)測方式以及實施現(xiàn)狀，并結(jié)合中國不良反應(yīng)監(jiān)測制度實踐情況，借鑒歐盟積累的經(jīng)驗，從完善法律體系和上報系統(tǒng)、制定額外監(jiān)測藥品納入原則與目錄、加強宣傳等方面構(gòu)建額外監(jiān)測制度框架，為豐富我國藥品上市后監(jiān)測模式，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

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