欧盟药品不良反应管理和上报指南简介  

Introduction of Management and Reporting of Adverse Reactions to Medicinal Products in European Union

作　　者：董铎[1] 刘巍[1] 杨乐[1] 刘翠丽[1] 程刚[1] 

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《中国药物警戒》2014年第10期611-613,617,共4页Chinese Journal of Pharmacovigilance

摘　　要：通过对于欧盟药品不良反应管理和上报指南的介绍,进一步了解欧盟对药品不良反应定义、报告收集、报告确认、报告随访、数据管理、质量管理等不良反应管理流程,为完善和发展我国药品不良反应报告和监测工作提供借鉴和参考。By introducing good pharmacovigilance prctice on management and reporting of adverse reactions to medicinal products in EU, it was more cleared to know the definition of adverse reactions and working process in EU, such ascollection of reports, validation of reports, follow-up of reports, data management, quality management. It provided the example and refrence for perfecting and developing drug adverse reaction reporting and monitoring system in China.

关 键 词：欧盟 药物警戒 不良反应 管理 上报 

分 类 号：R95[医药卫生—药学]