中国药物警戒 ›› 2018, Vol. 15 ›› Issue (11): 658-662.

• 药品上市许可持有人直接报告药品不良反应制度专栏 • 上一篇    下一篇

我国药品上市许可持有人开展上市后药品不良反应报告的现状及思考

曹璐娟1, 李馨龄2, 田春华2, 刘翠丽2, 赵霞1, *   

  1. 1 无锡市药品不良反应监测中心,江苏 无锡 214000;
    2 国家食品药品监督管理总局药品评价中心,北京 100022
  • 收稿日期:2019-01-09 修回日期:2019-01-09 出版日期:2018-11-20 发布日期:2019-01-09
  • 通讯作者: 赵霞,女,硕士,副主任药师,上市后药品安全监测。E-mail: 992296291@qq.com
  • 作者简介:曹璐娟,女,硕士,主管药师,药品不良反应监测。
  • 基金资助:
    国家药品不良反应监测中心2018年度调研项目：提升企业药品不良反应报告能力; 江苏省食品药品监督管理局2017-2018年度科研项目（20170109）

Current Status and Thinking of MAH on Post-marketing Adverse Drug Reaction Report of China

CAO Lujuan1, LI Xinling2, TIAN Chunhua2, LIU Cuili2, ZHAO Xia1, *   

  1. 1 Center for ADR Monitoring of Wuxi, Jiangsu Wuxi 214000, China;
    2 Center for Drug Reevaluation, CFDA, Beijing 100022, China
  • Received:2019-01-09 Revised:2019-01-09 Online:2018-11-20 Published:2019-01-09

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摘要： 目的 为我国建立药品上市许可持有人（MAH）直接报告药品不良反应（ADR）制度提供参考。方法 通过查阅国内外文献,综述我国MAH开展ADR报告的现状,深入剖析存在的问题,借鉴国外药物警戒经验,提出相应的建议。结果与结论 我国ADR报告和监测工作较发达国家起步较晚,MAH的试点工作也正处于探索和积累经验的阶段,MAH主动报告的数量较少,主体责任意识亟待加强。对此,我国有必要借鉴该项工作发展较成熟的欧盟、美国等国际经验,通过强化MAH主体责任意识、加强主动报告能力、拓宽信息收集渠道等措施,提高药物警戒水平。

关键词: 药品上市许可持有人, 上市后, 药品不良反应, 现状

Abstract: Objective To provide references for drug marketing authorization holder (MAH) of China to establish adverse drug reaction direct reporting system. Methods The related literatures were collected to summarize the current status of adverse drug reactions reporting, analyze the existing problems in depth, draw on the experience of foreign MAHs and put forward the corresponding countermeasures. Results & ConclusionThe monitoring and reporting of adverse drug reactions in China started relatively late, and the pilot work of MAH is also at the stage of accumulating experience. Few reports were actively collected and the main responsibility needs to be improved. In this regard, it is necessary for China to learn from the more mature experience of the European Union, the United States and other countries, and to raise the level of pharmacovigilance by strengthening the awareness of MAH's main responsibility, building professional gathering teams, and broadening the channels for information collection.

Key words: marketing authorization holder(MAH), post-marketing, adverse drug reactions, current status

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