中国药物警戒 ›› 2019, Vol. 16 ›› Issue (11): 649-653.
DOI: 10.19803/j.1672-8629.2019.11.02

• 药品上市许可持有人制度专栏 • 上一篇    下一篇

药品上市许可持有人直接报告不良反应制度实施问题研究

杨悦1,2   

  1. 1 沈阳药科大学工商管理学院,辽宁 沈阳 110016;
    2 沈阳药科大学国际食品药品政策与法律研究中心,辽宁 沈阳 110016
  • 收稿日期:2019-11-27 修回日期:2019-11-27 出版日期:2019-11-20 发布日期:2019-11-27
  • 作者简介:杨悦,女,博士,教授,药事管理。

Problems and Solutions to Implementation of Direct Reporting of Adverse Reaction System by MAHs

YANG Yue1,2   

  1. 1 School of Business Administration, Shenyang Pharmaceutical University, Shenyang Liaoning 110016, China;
    2 International Food and Drug Policy and Law Center, Shenyang Liaoning 110016, China
  • Received:2019-11-27 Revised:2019-11-27 Online:2019-11-20 Published:2019-11-27

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摘要： 回顾药品上市许可持有人（简称“持有人”）直接报告不良反应制度的实施进展,分析持有人直接报告不良反应面临的挑战,主要包括企业报告数量少、持有人直接报告遭遇医疗机构沟通障碍、医疗机构报告存在报告压力和顾虑、重复报告等。本研究从制度落实和实操层面思考如何借鉴国际先进经验、打消报告主体的报告顾虑、持有人的主动报告义务,畅通报告渠道避免重复报告等提出对策建议。

关键词: 药品上市许可持有人, 直接报告, 不良反应, 不良事件

Abstract: This paper reviewed the progress in the implementation of the system of direct reporting of adverse reactions by drug marketing authorization holders(MAHs), and analyzed the challenges facing MAHs, including the low report rate of ADRs from enterprises, communication barriers encountered by MAHs, pressure and concerns of medical institutions, and duplicate reporting. This study gave some tips on how to learn from foreign countries, address concerns over reporting on the part of all reporting parties, actively strengthen the reporting obligations of MAHs, open reporting channels and prevent duplicate reporting from the perspective of system implementation and practice.

Key words: marketing authorization holders(MAHs), direct reporting, adverse reaction, adverse event

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