In 2022, the pharmaceutical industry and Swissmedic conducted their ninth joint benchmarking study on approval times for human medicines. The comparison of the approval times of the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and Swissmedic directly shows the performance of Swissmedic as a small, independent national authorisation agency in relation to that of large, international reference authorities. It reveals that the Swissmedic authorisation time (Swissmedic + company time) for new active substances is shorter than that of the EMA for the first time. The reasons for this pleasing acceleration and other core findings of the study are summarised in the Executive Summary.
International comparison of Swiss approval times
In connection with this, Swissmedic would also like to draw attention to the latest publication of the Centre for Innovation in Regulatory Science (CIRS): R&D Briefing 85 – New drug approvals in six major authorities 2012-2021 compares the authorisation times of Swissmedic with those of Europe, Japan, Canada, Australia and the USA (Figure 1) and confirms the benchmarking study's findings of an acceleration. R&D Briefing 85 also shows that the proportion of facilitated and accelerated new authorisation procedures (“facilitated regulatory pathways”) has grown significantly over recent years (Figure 7). At the same times, submission gaps have been getting longer (Figure 16), which generally means later access to innovative medicinal products for patients.
When comparing the Executive Summary and R&D Briefing 85 from CIRS, it should be noted that the inclusion criteria for applications are not identical, which may lead to small numerical differences.