中国药物警戒 ›› 2013, Vol. 10 ›› Issue (11): 650-654.

• 政策与法规研究 • 上一篇    下一篇

ICH E2C（R2）定期风险-效益评估报告指导原则简介及启示

袁丽,杨悦*   

  1. 沈阳药科大学工商管理学院,辽宁沈阳 110016
  • 收稿日期:2013-07-15 修回日期:2016-03-09 出版日期:2013-11-08 发布日期:2016-03-09
  • 通讯作者: 杨悦,女,教授,药事法规与药品政策。 E-mail：yyue315@126.com
  • 作者简介:袁丽,女,硕士,药事法规与药品政策。

Introduction and Enlightments of ICH E2C(R2) Periodic Benefit-Risk Evaluation Reporting

YUAN Li ,YANG Yue*   

  1. College of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China
  • Received:2013-07-15 Revised:2016-03-09 Online:2013-11-08 Published:2016-03-09

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摘要： 药品上市后的安全性及有效性相对临床试验所得结论而言,可能会随实际用药人群及用药环境的复杂性而发现新的安全有效性问题,而定期风险- 效益报告则是一种重要的药物警戒工具,是识别药品风险- 效益特性改变的重要手段、是提示相关风险管理活动必要性的指示器,本文通过对国际上新的定期风险- 效益评估报告（PBRER）指导原则进行内容介绍,了解其中新的报告要求及原则,为我国未来相关工作的开展提供参考。

关键词: 定期安全性更新报告, 定期风险-效益报告, 信号, 风险评估

Abstract: Due to the complexity of targeted population and environment, new safety and efficacy problems of post-marketing drugs may be found differrent from the Conclusion s of clinical trials, while the PBRER is an important pharmacovigilance tool. It can be a means of determining changes in the benefit-risk profile and an indicator for the need of risk management initiatives. This paper introduced the content of the new Periodic Benefit-Risk Evaluation Reporting, aiming to understand the new concepts and principles of PBRER, and provide reference for related work in our country in the future.

Key words: PSUR, PBRER, signal, risk assessment

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