中国药物警戒 ›› 2012, Vol. 9 ›› Issue (3): 149-151.

• 管理及工作研究 • 上一篇    下一篇

个例安全性报告规范（ICH E2B）简介及应用

叶小飞1，郭晓晶1，赵璐1，2，贺佳1，*   

  1. 1 第二军医大学卫生统计学教研室，上海 200433；
    2 第二军医大学研究生管理大队，上海 200433
  • 收稿日期:2011-06-09 出版日期:2012-03-10 发布日期:2015-08-10
  • 通讯作者: 贺佳,女,博士生导师,药物流行病学及新药评价的统计分析。E-mail：hejia@smmu.edu.cn
  • 作者简介:叶小飞，男，博士，药物流行病学。
  • 基金资助:
    国家自然科学基金资助项目（No.30872186,No.81072388）,上海市优秀学科带头人计划（A类）（No.09XD1405500）,2010年上海市领军人才计划（022）,第二军医大学博士创新基金

An Introduction to and Application of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E2B

YE Xiao-fei1, Guo Xiao-jing1, ZHAO Lu1, 2, HE Jia1   

  1. 1 Department of Health Statistics, Second Military Medical University, Shanghai 200433, China;
    2 Brigade of Graduate Student Management, Second Military Medical University, Shanghai 200433, China
  • Received:2011-06-09 Online:2012-03-10 Published:2015-08-10

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摘要： 药品不良反应监测受到越来越多的关注，我国已建立药品不良反应自发呈报系统，并在逐步完善中。本文介绍了人用药品注册技术规范国际协调会中关于个例安全性报告规范的主要特点及现状，以期该规范能帮助提高我国药品不良反应监测水平。

关键词: 药品不良反应, 人用药品注册技术规范国际协调会

Abstract: More and more attention has been paid to the adverse drug reaction surveillance. Spontaneous reporting system has been developed in China and the authority has made great effort to improve the quality of surveillance. In this article, we presented a brief introduction to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, E2B. We expect that the adverse drug reaction surveillance in China will benefit a lot from this guideline.

Key words: adverse drug reaction, ICH