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.
关键词
新活性物质/监管/批准时间/监管促进路径/罕见病药
Key words
new active substance/regulation/approval time/facilitated regulatory pathway/rare disease drugs
维普
万方数据