中国药物警戒 ›› 2021, Vol. 18 ›› Issue (6): 507-509.
DOI: 10.19803/j.1672-8629.2021.06.03

• 《药物警戒质量管理规范》研究与实践专栏 • 上一篇    下一篇

跨国企业实施中国《药物警戒质量管理规范》的思考

张轶菁   

  1. 百济神州(北京)生物科技有限公司,北京 100022
  • 收稿日期:2021-04-21 出版日期:2021-06-15 发布日期:2021-07-02
  • 作者简介:张轶菁,女,硕士,药品不良反应监测。

Thoughts on How to Implement Good Pharmacovigilance Practices in China from a Global Pharmaceutical Industry Perspective

ZHANG Yijing   

  1. BeiGene (Beijing) Co.,Ltd., Beijing 100022, China
  • Received:2021-04-21 Online:2021-06-15 Published:2021-07-02

摘要: 目的 从企业角度包括药品上市许可持有人(简称“持有人”)和获准开展药物临床试验的药品注册申请人,探讨如何开展满足中国法律法规和规范文件要求的全生命周期药物警戒关键活动,跨国企业实施中国《药物警戒质量管理规范》的路径、机遇和挑战。方法 分析和总结跨国企业的工作现状,从实践操作角度提出实施《药物警戒质量管理规范》关键路径。结果与结论 《药物警戒质量管理规范》的实施对完善药物警戒体系至关重要。

关键词: 药物警戒, 药物警戒质量管理规范, 药物警戒体系, 质量管理

Abstract: Objective To explore the approaches to perform life-cycle pharmacovigilance and to implement Good Pharmacovigilance Practices (GVP) in order to fulfil the regulatory requirements in China from an industry perspective. Methods Based on the empirical data from global pharmaceutical companies, a systematic approach was taken to assess the current status of implementing GVP and make practical recommendations to the key steps of implementation of the regulation. Results and Conclusion The implementation of GVP is critical and essential to enhance pharmacovigilance system in pharmaceutical industry.

Key words: pharmacovigilance, good pharmacovigilance practices, pharmacovigilance system, quality management

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