中国药物警戒 ›› 2020, Vol. 17 ›› Issue (9): 567-571.
DOI: 10.19803/j.1672-8629.2020.09.05

• 法规与管理研究 • 上一篇    下一篇

世界卫生组织国际药物警戒合作中心的简介与启示

魏芬芳, 毛秋荣*, 成斌, 钟翎   

  1. 深圳市药物警戒和风险管理研究院,广东 深圳 518000
  • 收稿日期:2020-08-17 修回日期:2020-08-17 出版日期:2020-09-15 发布日期:2020-08-17
  • 通讯作者: *毛秋荣,男,硕士,主管医师·硕导,药品上市后安全性监测和评价。E-mail:maoqr@mail.amr.sz.gov.cn
  • 作者简介:魏芬芳,女,硕士,药师,药学。
  • 基金资助:
    2019年广东省药品不良反应监测中心委托项目“粤港澳大湾区药物警戒模式研究”

Introduction to WHO Collaborating Centre for Pharmacovigilance

WEI Fenfang, MAO Qiurong*, CHENG Bin, ZHONG Ling   

  1. Shenzhen Institute of Pharmacovigilance and Risk Management, Shenzhen Guangdong 518000, China
  • Received:2020-08-17 Revised:2020-08-17 Online:2020-09-15 Published:2020-08-17

摘要: 目的 了解世界卫生组织(WHO)国际药物警戒合作中心的相关情况,为我国设立药物警戒相关国际组织提供借鉴。方法 通过文献研究法和比较分析法,简要介绍了WHO国际药物警戒合作中心的组建发展、工作任务和学术交流方式等内容。结果 WHO出台了系列政策规范并支持合作中心的官方地位,地方政府也积极给予合作中心经费上的帮助。WHO通过多种合作方式成立了多个国际药物警戒合作中心。这些合作中心通过多种形式的交流培训促进区域药物警戒工作的开展。结论 借鉴国际做法,在国内沿海发达地区设立药物警戒相关国际性合作组织,以期提高我国在药物警戒领域的国际影响力,履行一定的国际义务,同时发挥对亚洲地区的带动和引领作用。

关键词: 国际药物警戒合作中心, 药品评价, 药品安全, 国际交流

Abstract: Objective To find out more about the WHO Collaborating Center for Pharmacovigilance so as to provide reference for the establishment of pharmacovigilance-related international organizations in China. Methods Based on literature study and comparative analysis, the WHO Collaborating Center for Pharmacovigilance was introduced in terms of founding, development missions and ways of academic exchange. Results The WHO has issued a series of policies and regulations to support the official status of this center, while local governments have also actively provided financial assistance to it. The WHO has established multiple international pharmacovigilance collaborating centers using a variety of collaborating methods. These collaborating centers promote regional pharmacovigilance in various forms of exchange or training. Conclusion It is recommended that China learn from international practices and set up pharmacovigilance-related international collaborating organizations in developed coastal areas in order to make China more influential in the field of pharmacovigilance, fulfill international obligations, and play a leading role in Asia.

Key words: WHO Collaborating Centre for Pharmacovigilance, drug evaluation, drug safety, international exchange

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