欧盟药物警戒额外监测制度简介与启示

2013年随着欧盟《良好药物警戒管理规范x》的生效，药品额外监测制度得到进一步完善。药品额外监测制度是一种通过建立监测目录、公开目录药品信息、采用特定标识等措施，鼓励医务人员和患者自发报告可疑不良反应，以便顺利开展上市后安全性评价，确保任何新的用药安全隐患能够被及时发现和有效避免的制度。通过介绍欧盟药物警戒额外监测制度，阐述我国药品不良反应（ADR）监测的现状，指出该制度是一种积极主动发现用药风险的尝试；学习和借鉴该制度，有助于我国弥补原有药品ADR报告系统低报、漏报等缺陷，主动开展用药安全监测，从而获得更加全面科学的结果。

Introduction and inspiration of pharmacovigilance additional monitoring in European Union

With the entry into force of The Good Pharmacovigilance Practice module X in 2013, the pharmacovigilance additional monitoring system had been further consummated. Additional monitoring is a system that encourage reporting adverse reaction, enhance post-authorization data collection for medicine products and collect drug safety information as early as possible. The process of additional monitoring includes creation and maintenance of the list, making the related information publicly, and marking the certain symbol on the package leaflet. The aim of this article is to introduce the additional monitoring in European Union, expound the current status of adverse drug reaction （ADR） monitoring in China, and provide a reference for constituting the additional monitoring policy, in order to improve the reporting of ADR, strengthen the ADR monitoring system, thus to obtain the comprehensive and scientific results.