This R&D Briefing presents the results from the Centre for Innovation in Regulatory Science (CIRS) annual analysis of new active substance (NAS) approvals by six major regulatory agencies: the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), the Japan Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA). The analysis focuses on 2024, while also retrospectively examining trends from 2015 to 2024.
Although median approval times can be a marker of agency performance and the time it takes to make medicines available to patients, other factors must be considered as illustrated below.
The use of facilitated regulatory pathways (FRPs) is a major element of the submission and approval strategy and is a focus of this year’s R&D Briefing.
The NAS list associated with this R&D Briefing will be available to download soon.
Please cite this article as: Lara J, Kermad A, Bujar M, McAuslane N (2025) R&D Briefing 101: New drug approvals in six major authorities 2015–2024: Trends in an evolving regulatory landscape. Centre for Innovation in Regulatory Science (CIRS), London, UK.
Questions?
If you have any questions or comments on this study, please get in touch with Dr Magda Bujar: mbujar@cirsci.org
