从定期安全性更新报告过渡到定期受益-风险评价报告：初步经验和挑战

中国药物警戒 ›› 2014, Vol. 11 ›› Issue (4): 210-215.

从定期安全性更新报告过渡到定期受益-风险评价报告：初步经验和挑战

张晓兰 LesterREICH 梁冰, Donald PUCCIO Craig HARTFORD

辉瑞有限公司全球研发中心全球安全和注册事务部,上海 201203

收稿日期:2013-09-25 修回日期:2016-02-03 出版日期:2014-04-08 发布日期:2016-02-03
作者简介:张晓兰,女,医学硕士,药品安全监测与风险管理。

Transitioning from Periodic Safety Update Report to Periodic Benefit-Risk Evaluation Report: Initial Experience and Challenges

ZHANG, Xiao-lan, Lester REICH, LIANG Bing, Donald PUCCIO, Craig HARTFORD

Worldwide Safety and Regulatory, Worldwide Research and Development, Pfizer Inc.,Shanghai 201203, China

Received:2013-09-25 Revised:2016-02-03 Online:2014-04-08 Published:2016-02-03

摘要/Abstract

摘要： 人用药品注册技术要求国际协调会议（ICH）提供了定期安全性更新报告指南（PSUR,ICH E2C（R1））和新的定期受益-风险评价报告指南（PBRER,ICH E2C（R2））。PBRER由PSUR演变而来,实现了从比较传统的获批后药物警戒定期总结报告到现代定期受益-风险评价总结报告的转变,根据累积信息对批准上市产品做出最新的受益-风险评价。通过总结ICH E2C PSUR指南和PBRER指南的主要区别,介绍了某跨国制药公司在由编写PSUR改为编写PBRER的转变过程中所积累的初步经验及其遇到的挑战,讨论了中国在推进药物警戒系统的背景下实行PBRER的可能性。

关键词: 人用药品注册技术要求国际协调会议, 定期安全性更新报告, 药物警戒, 药品上市后监测

Abstract: Periodic safety update reports addressing the worldwide safety experience of medicinal products must be provided to regulatory authorities at defined time intervals after products are marketed. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH) provides guidelines for the Periodic Safety Update Report((PSUR), ICH E2C(R1) Guideline) and the more recent Periodic Benefit-Risk Evaluation Report((PBRER), ICH E2C(R2) Guideline). The PBRER is an evolution of the PSUR, enabling a shift from the more traditional post-approval pharmacovigilance periodic summary report to a modern periodic summary report presenting the current benefit-risk assessment of the approved indications for a product based on cumulative efficacy and safety information. This paper summarizes key differences between the ICH E2C PSUR and PBRER Guidelines, describes the initial experience and challenges encountered by a multinational pharmaceutical company in effecting the transition from PSUR to PBRER format and content, and discusses the potential for implementation of the PBRER in China in the context of China's evolving pharmacovigilance system.

Key words: international conference on harmonization(ICH), periodic safety update report, pharmacovigilance, postmarketing product surveillance

中图分类号:

R951

张晓兰 LesterREICH 梁冰, Donald PUCCIO Craig HARTFORD. 从定期安全性更新报告过渡到定期受益-风险评价报告：初步经验和挑战[J]. 中国药物警戒, 2014, 11(4): 210-215.

ZHANG, Xiao-lan, Lester REICH, LIANG Bing, Donald PUCCIO, Craig HARTFORD. Transitioning from Periodic Safety Update Report to Periodic Benefit-Risk Evaluation Report: Initial Experience and Challenges[J]. Chinese Journal of Pharmacovigilance, 2014, 11(4): 210-215.

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