欧盟新法规下的药物警戒制度简介

Introduction of European Union Pharmacovigilance System facing New Regulation

通过对于欧盟药物警戒法规修订情况的介绍,进一步了解欧盟药物警戒制度框架的组成,并且清晰了欧盟药物警戒系统和质量体系、药物警戒系统主文件、药物警戒检查、风险管理系统等制度形式的具体内容,为完善和发展我国药品不良反应报告和监测体系提供借鉴和参考。

By introducing the revision of European Union（EU） Pharmocovigilance regulation, it helped to know the structure of EU Pharmacovigilance system better. And it also clearly showed the contents of the system, such as Pharmacovigilance Systems and their Quality Systems, Pharrnacovigilance System Master File, Pharmacovigilance Inspections, Risk Management Systems. It provided the example and reference for perfecting and developing Adverse Drug Reaction Reporting and Monitoring System of China.