欧盟新法规下的药物警戒制度简介

摘要/Abstract

摘要： 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。

关键词: 欧盟, 新法规, 药物警戒, 制度

Abstract: 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, Pharmacovigilance 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.

Key words: European Union, new regulation, pharmacovigilance, system

董铎, 吴桂枝, 程刚. 欧盟新法规下的药物警戒制度简介[J]. 中国药物警戒, 2012, 9(11): 662-665.

DONG Duo, WU Gui-zhi, CHENG Gang. Introduction of European Union Pharmacovigilance System facing New Regulation[J]. Chinese Journal of Pharmacovigilance, 2012, 9(11): 662-665.

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