欧盟药物警戒检查制度简介  

Introduction of pharmacovigilance inspection in European Union

作　　者：董铎[1,2] 孙利华[1] 杨晓茹[3] 

机构地区：[1]沈阳药科大学工商管理学院,沈阳110016 [2]国家食品药品监督管理局药品评价中心,北京100045 [3]牡丹江医学院第二附属医院,牡丹江157000

出　　处：《中国新药杂志》2012年第8期832-835,共4页Chinese Journal of New Drugs

摘　　要：文章旨在了解欧盟药物警戒检查制度的背景与实施,为我国开展检查工作提供借鉴和参考。根据欧盟法规,欧洲药品管理局建立了一套包括检查程序、检查内容在内的完整体系。建立检查制度对于监督和促进生产企业开展药品不良反应报告和监测工作具有重要作用,我国《药品不良反应报告和监测管理办法》已为此奠定了实施基础,但尚缺乏具体实施的程序与规范,值得今后深入研究和实践。The aim of this article is to understand the background and implement of pharmacovigilance inspeciton in European Union（EU）,thus to provide reference for inspection in China.In line with EU legislation,EMA has established a set of integrated system including inspection procedure and contents.The establishment of inspection system plays significant roles in supervising and facilitating manufacturers to carry out ADR reporting and monitoring.In China,the Provisions on ADR Reporting and Monitoringhas laid foundation for implementing inspection,but there still lacks of concrete procedures and guidelines which need to be intensively studied in the future.

关 键 词：欧盟 药物警戒 药品不良反应 检查 

分 类 号：R95[医药卫生—药学]