欧盟新的药物警戒法规简介与启示

Brief Introduction and its Implication of New Pharmacovigilance Legislation in EU

目的对欧盟新药物警戒法进行介绍,为完善我国药品不良反应报告和监测体系提供参考。方法通过查阅国内外文献,应用文献研究的方法进行分析。结果欧盟药物警戒当前所关注的焦点问题主要集中在收集药品安全性信息,分析和挖掘药品数据信息,开展围绕公众健康监管活动以及与利益相关者进行有效沟通。结论我国应借鉴欧盟新药物警戒法,提高我国药品不良反应报告和监测能力。

Objective According to the introduction of new pharmacovigilance legislation in EU,suggestions were put forward to provide the example and reference for perfecting and developing adverse drug reation reporting and monitoring system of China.Methods Literature study was used to analyze the foreign and domestic materials.Results New pharmacovigilance legislation in EU focuses on collection of key information on medicines,better analysis and understanding of data and information,regulatory action to safeguard public health and communication with stakeholders.Conclusion We should learn from the new EU pharmacovigilance law to improve capabilities of adverse drug reaction reporting and monitoring.