中国药物警戒 ›› 2019, Vol. 16 ›› Issue (11): 662-665.
DOI: 10.19803/j.1672-8629.2019.11.04

• 药品上市许可持有人制度专栏 • 上一篇    下一篇

药品不良反应直报系统强化药品上市许可持有人主体责任落实

侯永芳, 刘红亮, 郑明节*   

  1. 国家药品监督管理局药品评价中心,北京 100022
  • 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
  • 通讯作者: 郑明节,女,高级工程师,药品不良反应监测。E-mail:zhengmingjie@cdr-adr.org.cn
  • 作者简介:侯永芳,男,高级工程师,硕士,药品不良反应监测。

Direct Reporting System for Adverse Drug Reactions Strengthens Fulfillment of Responsibilities of Marketing Authorization Holders

HOU Yongfang, LIU Hongliang, Zheng Mingjie*   

  1. Center for Drug Reevaluation,NMPA,Beijing 100022, China
  • Received:2019-11-27 Revised:2019-11-27 Online:2019-11-20 Published:2019-11-27

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摘要： 目的 从政策背景、具体功能等方面介绍药品上市许可持有人药品不良反应直接报告系统,以期为相关方理解提供参考。方法 从药品不良反应直接报告功能、风险数据反馈功能、产品信息维护功能等方面介绍我国药品上市许可持有人不良反应直接报告系统。结果与结论 药品上市许可持有人药品不良反应直接报告系统的上线和应用后,监管部门能够从药品上市许可持有人收集更多高质量的药品安全性数据,并能够将风险信息及时向药品上市许可持有人进行反馈,助力药品上市许可持有人主体责任落实,但E2B（R3）在直报系统中应用将面临巨大挑战。

关键词: 药品上市许可持有人, 药品不良反应, 系统, 反馈

Abstract: Objective To introduce the direct reporting system for adverse drug reactions by the marketing authorization holder (MAH), in terms of the policy background and specific functions. Methods The direct reporting system for adverse reactions by MAHs in China was illustrated by introducing such functions of the system as direct reporting of adverse drug reactions, risk data feedback, and product information maintenance. Results & Conclusion Since the direct reporting system for adverse reactions by MAHs in China was established, the regulators have been able to collect drug safety data of better quality from MAHs and promptly feedback the risk information to MAHs. The system can help MAHs to fulfill the main responsibilities. However, the application of E2B (R3)in the direct reporting system will face enormous challenges.

Key words: marketing authorization holder, adverse drug reaction, system, feedback

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