欧盟药品上市后额外监测制度及现状分析

Introduction and current situation analysis of additional monitoring system in European Union

欧盟为加强对特定药品不良反应的监测力度,及时收集用药信息,引入了药品上市后额外监测制度。该制度鼓励医务人员和患者自发报告可疑的不良反应,以便对药品进行安全性评估。介绍了欧盟额外监测制度的管理程序、监测方式以及实施现状,并结合中国不良反应监测制度实践情况,借鉴欧盟积累的经验,从完善法律体系和上报系统、制定额外监测药品纳入原则与目录、加强宣传等方面构建额外监测制度框架,为丰富我国药品上市后监测模式,完善药物警戒体系提供参考。

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.