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。
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.
作者
祝倩
单秋月
袁晔
方薇
宋红
梁津津
曹铁军
ZHU Qian;SHAN Qiuyue;YUAN Ye;FANG Wei;SONG Hong;LIANG Jinjin;CAO Tiejun(Beijing Stemexcel Technology Co.,Ltd,Beijing 100000,China;Tianjin Center for ADR monitoring,Tianjin 300191,China)
出处
《中国药物警戒》
2020年第6期357-360,共4页
Chinese Journal of Pharmacovigilance
关键词
定期安全性更新报告
定期获益-风险评估报告
差异
periodic safety update report
periodic benefit-risk assessment report
differences
作者简介
祝倩,女,硕士,药物警戒;通信作者:单秋月,女,博士,药物警戒。E-mail:shanqiuyue@stemexcel.com。
