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中国医药导刊 ›› 2021, Vol. 23 ›› Issue (10): 789-794.

所属专题: 《药物警戒质量管理规范》(GVP)

• GVP专栏 • 上一篇    下一篇

我国与欧盟药物警戒负责人(QPPV)岗位职责和选聘探讨与思考

  徐菊萍1,胡骏2,万帮喜1,魏晓菲1,王广平2*   

  1. 1.浙江太美医疗科技股份有限公司,上海 200233; 2.上海市药品和医疗器械不良反应监测中心,上海 200040
  • 收稿日期:2021-08-23 修回日期:2021-10-11 出版日期:2021-10-28 发布日期:2021-10-28
  • 基金资助:
    中国药品监督管理研究会2021年度研究课题[项目名称:药品良好监管体系规范(GRP)的建设原则和框架研究]

Discussion and Thoughts on the Job Responsibilities and Selectionof QPPV between China and EU

  1. 1. Zhejiang Taimei Medical Technology Co., Ltd.,Shanghai 200233,China;  2.Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring, Shanghai 200040,China
  • Received:2021-08-23 Revised:2021-10-11 Online:2021-10-28 Published:2021-10-28

摘要: 目的:比较我国与欧盟药物警戒负责人(QPPV)的任职资格、岗位职责要求的差异,分析探索我国QPPV资质职责要求和选聘外包可行性,以期为药品上市许可持有人(MAH)聘用合适的QPPV提供借鉴。方法:分析我国与欧盟有关QPPV的任职资格、岗位要求和法规要求,以及QPPV角色外包的可能性。结果:我国与欧盟《药物警戒质量管理规范》(GVP)对QPPV均有明确的专业要求,但在具体承担的法律责任上有所差异。我国QPPV更多为技术层面负责人;欧盟容许MAH聘用外部人员作为QPPV,但我国GVP中尚无明确要求。结论:相较于欧盟QPPV要求,我国MAH的QPPV条件相对宽松,政府亟须加强MAH选聘外部QPPV的合规性管理。

关键词: font-size:medium, ">药物警戒质量管理规范;药物警戒负责人;药物警戒责任;选聘;外包

Abstract: Objective:By comparing the differences in the qualifications and job responsibilities of qualified person for pharmacovigilance (QPPV) between China and EU, to discuss the possibility of outsourced QPPV in China,so as to provide references for marketing authorization holders (MAH) to find a qualified QPPV.Methods:Analyze the qualifications, job responsibilities and regulatory requirements that relate to QPPV both in China and EU. Meanwhile, the possibility of QPPV outsourcing was discussed. Results:Chinese QPPV is more technically oriented while the EU allows MAH to hire external personnel as QPPV, but there is no clear requirement for this in the Chinese GVP.Both of China and EU Good Pharmacovigilance Practices (GVP) clearly state professional requirements of QPPV, but differ in the specific legal responsibilities they assume. To meet EU GVP requirements, EU accepts MAH to hire QPPV from a third party as an individual staff. But currently there is no such requirement in China GVP. Conclusion:Compared with the EU QPPV requirements, the QPPV conditions for Chinese MAH are relatively lenient, and the government needs to strengthen the compliance management of MAH in selecting and hiring external QPPV.
  

Key words: Good Pharmacovigilance Practices;Qualified person for pharmacovigilance;Pharmacovigilance responsibilities, Selection, Outsourcing

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