中国药物警戒 ›› 2014, Vol. 11 ›› Issue (10): 611-613.

• 政策与法规研究 • 上一篇    下一篇

欧盟药品不良反应管理和上报指南简介

董铎, 刘巍, 杨乐, 刘翠丽, 程刚   

  1. 国家食品药品监督管理总局药品评价中心,北京 100045
  • 收稿日期:2014-08-02 修回日期:2016-02-03 出版日期:2014-10-08 发布日期:2016-03-02
  • 作者简介:董铎,女,博士,副主任药师,药品不良反应监测。

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

DONG Duo, LIU Wei, YANG Le, LIU Cui-li, CHENG Gang   

  1. Center For Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2014-08-02 Revised:2016-02-03 Online:2014-10-08 Published:2016-03-02

PDF (PC)

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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。

关键词: 欧盟, 药物警戒, 不良反应, 管理, 上报

Abstract: 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.

Key words: European Union, pharmacovigilance, adverse reactions, management, reporting

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