Analysis of New Drug Approvals by Six Major Authorities(2014-2023):Evolving Regulatory Landscape and Facilitated Regulatory Pathways
This article presents the annual analysis results of new active substance(NAS)approvals by the Centre for Innovation in Regulatory Science(CIRS),with a focus on the 2023 NAS approvals and a review of the trends from 2014 to 2023.The analysis shows that while there are still significant differences in median approval times across the six regulatory authorities the variation in time from submission to the end of scientific assessment has narrowed.The FDA remains the agency with the highest number of NAS approvals and the EMA has shown a notable increase in approvals.The proportion of orphan drugs has generally shown an upward trend,which can be attributed to factors such as company submission strategies and scale,unmet medical needs,regulatory review speed,the use of risk-based review pathways,and collaborative or work-sharing review mechanisms.
new active substanceregulationapproval timefacilitated regulatory pathwayrare disease drugs
Juan Lara、Magda Bujar、Adem Kermad、Neil McAuslane、Anna Somuyiwa、曾亚莉、李丹
万方数据
维普
