| 欧盟药物警戒信息监管体系的分析与借鉴 |
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| 引用本文： | 海颖.欧盟药物警戒信息监管体系的分析与借鉴[J].中国执业药师,2011,8(2):30-33. |
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| 作者姓名： | 海颖 |
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| 作者单位： | 国家食品药品监督管理局药品评价中心,北京,100045 |
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| 摘 要： | 欧盟的药物警戒信息监管体系对欧洲的药物监管和不良反应监测方面发挥了重要的作用.本文介绍了欧盟药物警戒体系的主要机构,欧盟药物警戒信息体系的组成,包括不良反应报告体系、上市后研究、风险管理策略等.目的是为我国的不良反应监测体系和药物警戒的发展提供借鉴和启示.
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| 关 键 词： | 药物警戒信息 欧盟 不良反应监测 |
The Analysis and Suggestions of European Pharmacovigilance Supervision Systems |
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| Authors: | Hai Ying |
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| Institution: | Hai Ying(Center for Drug Reevaluation of the State Food and Drug Administration,Beijing 100045,China) |
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| Abstract: | EU pharmacovigilance information monitoring system plays an important role in drug supervision and adverse reaction monitoring in Europe. This paper presented the major agencies and the components of EU pharmacovigilance system, including adverse reaction reporting system, post-marketing study, risk management strategy etc. The objective is for reference and inspiration for the adverse reaction monitoring system and the development of pharmacovigilance in our country. |
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| Keywords: | Pharmacovigilance Information EU Adverse Reaction Monitoring |
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