中国药物警戒 ›› 2021, Vol. 18 ›› Issue (6): 510-513.
DOI: 10.19803/j.1672-8629.2021.06.04

• 《药物警戒质量管理规范》研究与实践专栏 • 上一篇    下一篇

《药物警戒委托协议撰写指导原则（试行）》要点简介

杨乐, 田春华*, 夏东胜, 王丹, 刘翠丽, 汤韧, 于洪礼, 彭丽丽, 王刚   

  1. 国家药品监督管理局药品评价中心,北京 100022
  • 收稿日期:2021-01-22 出版日期:2021-06-15 发布日期:2021-07-02
  • 通讯作者: *田春华,女,硕士,副主任药师,药品不良反应监测与评价。E-mail：tianchunhua@cdr-adr.org.cn
  • 作者简介:杨乐,男,本科,副主任药师,药品不良反应监测与评价。
  • 基金资助:
    重大新药创制国家科技重大专项2017年度（2017ZX09101001-001-003）

Brief Introduction on the Guideline for the Pharmacovigilance Delegation Agreement (Pilot Version)

YANG Le, TIAN Chunhua*, XIA Dongsheng, WANG Dan, LIU Cuili, TANG Ren, YU Hongli PENG Lili, WANG Gang   

  1. Center For Drug Reevaluation, NMPA, Beijing 100022, China
  • Received:2021-01-22 Online:2021-06-15 Published:2021-07-02

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摘要： 目的 为药品上市许可持有人与受托方规范开展药物警戒委托工作提供参考。方法 从文件起草者视角,围绕起草背景、上市后药物警戒委托现状、指导原则要点等主要内容进行介绍。结果与结论 《药物警戒委托协议撰写指导原则（试行）》已于2020年6月4日正式发布,作为新时代我国首个关于药品上市许可持有人如何开展药物警戒委托工作的规范性文件,旨在为相关各方提供帮助与启示,并将在实践中不断调整和完善。

关键词: 药物警戒, 委托协议, 药品上市许可持有人, 受托方

Abstract: Objective To provide an important reference for drug marketing authorization holders and consignee to carry out pharmacovigilance commission. Methods From the perspective of drafters, the regulation is related with the drafting background, the status of post marketing pharmacovigilance Commission, guidelines and key points were introduced. Results and Conclusion The guidelines for the Pharmacovigilance delegation agreement (pilot version) has been officially released on June 4, 2020. As the first normative documentation on how to carry out pharmacovigilance delegation for drug marketing authorization holders in China in the new era, it aims to provide guide and enlightenment for relevant parties, and will be continuously adjusted and improved in practice.

Key words: pharmacovigilance, delegation agreement, drug marketing authorization holder, consignee

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