中国药物警戒 ›› 2019, Vol. 16 ›› Issue (10): 588-590.
DOI: 10.19803/j.1672-8629.2019.10.03

• ICH E2B（R3）转化与实施专栏 • 上一篇    下一篇

我国上市后个例安全性报告实施E2B(R3)思路及探讨

侯永芳1, 方恺睿1, 漆燕1, 王青2, 刘红亮1   

  1. 1 国家药品监督管理局药品评价中心,北京 100022;
    2 清华大学信息科学技术学院,北京 100084
  • 收稿日期:2019-10-24 修回日期:2019-10-24 出版日期:2019-10-20 发布日期:2019-10-24
  • 作者简介:侯永芳,男,硕士,高级工程师,药品不良反应监测。
  • 基金资助:
    国家药品不良反应监测中心资助项目（2018IX001）：E2B数据标准研究

Thoughts on Implementing E2B(R3) in Individual Case Safety Reports in China

HOU Yongfang1, FANG Kairui1, QI Yan1, WANG Qing2, LIU Hongliang1   

  1. 1 Center for Drug Reevaluation, NMPA,Beijing 100022, China;
    2 School of Information Science and Technology of Tsinghua University,Beijing 100084, China
  • Received:2019-10-24 Revised:2019-10-24 Online:2019-10-20 Published:2019-10-24

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摘要： 目的 介绍我国上市后个例安全性报告E2B(R3)实施思路。方法 阐述E2B(R3)实施涵义和实施路径,探讨转化实施面临挑战及有关建议。结果与结论 E2B(R3)的实施有利于个例安全性报告信息的共享和交换,上市后个例安全性报告实施具有较大挑战,需结合我国药品不良反应监测发展水平逐步转化和实施。

关键词: E2B(R3), 个例安全性报告, 实施

Abstract: Objective To offer thoughts on implementation of E2B(R3) in individual case safety reports (ICSR)in China. Methods By interpreting the significance and ways of implementating E2B (R3), the challenges to and countermeasures for the implementation of E2B (R3) were explored. Results & Conclusion The implementation of E2B (R3) is conducive to the sharing and exchange of ICSR. There are many formidable challenges. E2B (R3) needs to be gradually implemented based on the level of development of adverse drug reaction monitoring.

Key words: E2B(R3), ICSR, implementation

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