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浅析国外药物警戒受权人制度对我国药品不良反应监测工作的启示 被引量：13

QPPV and Its Implication for China's Adverse Drug Reaction Monitoring Work
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摘要 目的简要介绍国外药品药物警戒受权人相关制度,为建立和完善我国药品不良反应监测联系人制度提供借鉴和参考。方法通过查阅国内外文献,应用文献研究的方法调研欧盟和澳大利亚的药物警戒受权人(QPPV)的相关制度,并进行分析。结果欧盟、澳大利亚均建立了严谨的药物警戒受权人制度,可为我国建立药品不良反应监测联系人制度提供宝贵的实践经验。结论吸收借鉴国际经验,结合我国的药品安全监管特点,应进一步建立和完善我国的药品不良反应监测联系人制度,提高药品不良反应监测水平。 Objective To provide suggestions for china to setup and improve the Contact Person of ADR through the brief introduction of Qualified Person for Pharmacovigilance （QPPV）. Methods Based on literature review, the QPPV of EU and Australia was investigated and analyzed. Results QPPV has been set up in EU and Australia, it can provide valuable practical experience for our country to establish the Contact Person of ADR. Conclusion Combing with the feature of drug safety supervision in our country and using for reference of the international experience, we should establish and complete our country＆#39;s Contact Person of ADR in order to improve the level of adverse drug reaction monitoring.
作者 彭丽丽 沈璐 董铎 刘巍 张华 郭雪 李馨龄 程刚
机构地区 国家食品药品监督管理总局药品评价中心
出处 《中国药物警戒》 2015年第2期89-91,共3页 Chinese Journal of Pharmacovigilance
关键词 欧盟 药物警戒受权人 药品不良反应监测联系人 启示 EU QPPV the Contact Person of ADR implication
分类号 R95 [医药卫生—药学]
  • 相关文献

参考文献11

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二级参考文献29

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共引文献42

同被引文献129

引证文献13

二级引证文献84

中国药物警戒
2015年 第2期

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