中国药物警戒 ›› 2020, Vol. 17 ›› Issue (6): 357-360.
DOI: 10.19803/j.1672-8629.2020.06.08

• 法规与管理研究 • 上一篇    下一篇

中国药品定期安全性更新报告及ICH定期获益风险评估报告撰写差异浅析

祝倩1, 单秋月1*, 袁晔2, 方薇1, 宋红1, 梁津津1, 曹铁军1   

  1. 1 北京斯丹姆赛尔技术有限责任公司,北京 100000;
    2 天津市药品不良反应监测中心,天津 300191
  • 收稿日期:2019-08-29 修回日期:2020-06-22 出版日期:2020-06-15 发布日期:2020-06-01
  • 通讯作者: *单秋月,女,博士,药物警戒。E-mail：shanqiuyue@stemexcel.com
  • 作者简介:祝倩,女,硕士,药物警戒。

Analysis of Differences between Periodic Safety Update Reports for Marketed Drugs in China and Periodic Benefit-risk Evaluation Report in ICH

ZHU Qian1, SHAN Qiuyue1*, YUAN Ye2, FANG Wei1, SONG Hong1, LIANG Jinjin1, CAO Tiejun1   

  1. 1 Beijing Stemexcel Technology Co., Ltd, Beijing 100000, China;
    2 Tianjin Center for ADR monitoring, Tianjin 300191, China
  • Received:2019-08-29 Revised:2020-06-22 Online:2020-06-15 Published:2020-06-01

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摘要： 目的 浅析国内药品定期安全性更新报告以及人用药品注册技术要求国际协调会议（international council for harmonization,ICH）定期获益-风险评估报告要求上的撰写差异。方法 通过比较ICH（R1)（上市药品定期安全性更新报告,periodic safety update reports for marketed drugs,PSUR）、ICH（R2）（定期获益-风险评估报告,periodic benefit-risk evaluation report,PBRER）以及国内相关法规内容,总结我国PSUR与ICH PBRER监管要求的差异。结果 在时限上,我国所有药品撰写递交时限为60日,而ICH要求根据其药品的特性分为70个日历日或90个日历日。在内容上,我国主要是收集报告期内安全性相关内容,而ICH要求收集报告期内及累积的安全性和疗效相关的内容,并且增加了信号检测和评价方法的描述。结论 尽管我国与ICH的要求还有差异,但随着药物警戒活动的深入开展,对上市许可持有人的要求越来越高,未来会更注重对药物风险获益的整体评估,逐渐缩小差异。

关键词: 定期安全性更新报告, 定期获益-风险评估报告, 差异

Abstract: Objective To analyze the differences between periodic safety update reports for marketed drugs in China and periodic benefit-risk evaluation report in International Council for Harmonization (ICH). Methods The differences of periodic safety update reports between China and ICH is performed by comparing ICH (R1) (periodic safety update reports for marketed drugs, PSUR), ICH (R2) (periodic benefit-risk evaluation report, PBRER) and relevant laws and regulations in China. Results In terms of time requirement, the deadline for writing and submitting PSUR in China is 60 days, while the deadline for writing and submitting ICH is divided into 70 calendar days or 90 calendar days according to the characteristics of its drugs. In terms of content, China mainly collects safety-related content during the reporting period, while the ICH collects safety-related and efficacy-related content during the reporting period and accumulated content in the early stage. PBRER also includes a description of signal detection and evaluation methods. Conclusion Although there are differences between the requirements of China and ICH, China will pay more attention to the benefit-risk evaluation and the differences will gradually narrow in the future with the development of pharmacovigilance activities as well as increasing demands on marketing authorization holders.

Key words: periodic safety update report, periodic benefit-risk assessment report, differences

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