中国药物警戒 ›› 2023, Vol. 20 ›› Issue (9): 967-970.
DOI: 10.19803/j.1672-8629.20220582

• 药物警戒质量管理规范实践专栏 • 上一篇    下一篇

药品上市许可持有人药物警戒远程检查流程探讨

夏旭东1, 黎美霞2, 孙阳3, 杨胜亚1,*   

  1. 1河南省药品评价中心,河南 郑州 450000;
    2河南大学药学院,河南 开封 475001;
    3国家药品监督管理局,北京 100037
  • 收稿日期:2022-09-30 出版日期:2023-09-15 发布日期:2023-09-14
  • 通讯作者: *杨胜亚,男,本科,正高级工程师,药物警戒与药品风险管理。E-mail: hnypgmp@163.com
  • 作者简介:夏旭东,男,硕士,高级工程师,药品不良反应监测与评价。
  • 基金资助:
    河南省科技攻关计划（212102311047）

Processes of remote inspection of pharmacovigilance for marketing authorization holders

XIA Xudong1, LI Meixia2, SUN Yang3, YANG Shengya1,*   

  1. 1Henan Drug Reevaluation Center, Zhengzhou Henan 450000, China;
    2School of Pharmacy, Henan University, Kaifeng Henan 475001, China;
    3National Medical Products Administration, Beijing 100037, China
  • Received:2022-09-30 Online:2023-09-15 Published:2023-09-14

PDF (PC)

567

摘要： 目的 探讨我国药品监督管理部门对药品上市许可持有人开展药物警戒远程检查的一般流程和注意事项。方法 参照现场检查工作流程,讨论信息化手段和工具在远程检查具体环节中的应用。结果与结论 基于当前信息网络技术,开展药物警戒远程检查可以达到检查目的,并有助于提升检查效率,节约时间成本,更早发现和解决药品安全性问题。

关键词: 药物警戒, 药物警戒质量管理规范, 药品上市许可持有人, 检查, 远程

Abstract: Objective To explore the normal processes of and considerations for remote inspection of pharmacovigilance for marketing authorization holders licensed by China's drug regulatory authorities. Methods The application of information tools and instruments in a particular part of remote inspection was discussed according to the on-site inspection workflow. Results and Conclusion Based on current information network technology, remote inspection of pharmacovigilance can achieve its purpose and help to improve efficiency, save time and costs, and identify and address drug safety issues earlier.

Key words: pharmacovigilance, Guidelines for Good Pharmacovigilance Practice(GVP), marketing authorization holder(MAH), inspection, remote

中图分类号: