2012~2021年国外六大监管机构新药审评情况分析:聚焦监管促进路径和国际化  

Analysis of New Drug Approvals by Six Major Regulatory Authorities 2012-2021:Focus on Facilitated Regulatory Pathways and Internationalization

作　　者：Juan Lara Magda Bujar Neil McAuslane 张颖(编译) Juan Lara;Magda Bujar;Neil McAuslane;ZHANG Ying(Center for Innovation in Regulatory Science(CIRS);Clerivate Analytics Information Services(Beijing)Company Ltd.)

机构地区：[1]国际监管科学创新研究中心(CIRS) [2]科睿唯安信息服务(北京)有限公司

出　　处：《中国食品药品监管》2023年第6期12-29,共18页China Food & Drug Administration Magazine

摘　　要：本文介绍了国际监管科学创新中心(CIRS)对六大监管机构批准的新活性物质(NAS)的年度分析结果,重点分析了2021年NAS批准情况,并回顾了2012~2021年的情况。通过分析可以看出,尽管中位批准时间可以作为考量监管机构工作效率和药物获批上市所需时间的重要指标,但同时也需要考虑其他因素,包括监管促进路径(FRP)、NAS的国际化以及新数据来源[包括真实世界数据(RWD)]的使用等。This R&D Briefing presents the annual analysis results of new active substance(NAS)approvals by the Centre for Innovation in Regulatory Science(CIRS).It focuses on the NAS approvals in 2021 while also reviewing the period from 2012 to 2021.The analysis highlights that while median approval time can be a marker of agency performance and the time required to make medicines available to patients,other factors need to be taken into account as well.This R&D Briefing focuses on factors such as facilitated regulatory pathways(FRP),internationalization of NAS,and the use of novel data sources,including realworld data(RWD).

关 键 词：监管机构 批准时间 监管促进路径 

分 类 号：R95[医药卫生—药学]