中国药物警戒 ›› 2016, Vol. 13 ›› Issue (3): 159-161.

• 法规与管理研究 • 上一篇    下一篇

浅议生产企业如何履行药品上市后安全第一责任人的职责

彭丽丽,范燕,李馨龄   

  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:2016-02-04 修回日期:2016-04-12 出版日期:2016-03-20 发布日期:2016-04-12
  • 通讯作者: 李馨龄,男,副主任医师,上市后药械安全监测。E-mail:lixinling @ cdr-adr.org.cn
  • 作者简介:彭丽丽,女,硕士,工程师,中药学。

Discussion on How Drug Manufacturers Fulfill the First Person Responsibilities of Post-marketing Drug Safety

PENG Li-Li, FAN Yan, LI Xin-ling   

  1. Centre for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2016-02-04 Revised:2016-04-12 Online:2016-03-20 Published:2016-04-12

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摘要： 目的 帮助药品生产企业充分认识药品不良反应监测工作的意义及其在监测工作中的主体地位。方法 从国内对药品生产企业的相关法规要求的基础上分析了国内药品生产企业在药品不良反应报告与监测的现状及存在的问题,提出了我国药品生产企业如何开展和落实药品不良反应报告和监测工作的相关建议。结果 与结论 药品生产企业应当进一步加强对药品不良反应监测与报告的认识和理解,构建全面的质量管理体系,设置专门的机构和人员负责药品不良反应监测工作,并加强企业内部的培训宣传工作,积极落实企业作为“药品安全第一责任人”的责任。

关键词: 药品生产企业, 药品上市后研究, 第一责任人

Abstract: Objective To help drug manufacturers to understand and recognize the significance and their dominant position in the adverse drug reaction (ADR) monitoring work. Methods Based on the analysis of relevant regulations, the problems of the domestic drug manufacturers in ADR reporting and monitoring were analyzed, and related suggestions on how to develop and implement ADR reporting and monitoring were put forward. Results and Conclusion Drug manufacturers should strengthen their cognition and understanding of ADR monitoring and reporting, structure the quality management system, set up expert organizations and full-time personnel responsible for ADR monitoring. At the same time, drug manufacturers should strengthen their internal training to commit the responsibility of “drug safety first person” actively.

Key words: drug manufacturer, post-marketing study , the first person responsible

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