Benchmarking study 2024

In 2024, Swissmedic authorised 46 new active substances (NA NAS) and 70 additional indications (IE), as well as numerous known active substances (KAS) with and without innovation, and extensions for new dosage forms. The benchmarking study 2024 confirms stable throughput times at Swissmedic for NA NAS. Consequently, the Swiss authority is catching up with EMA in the international comparison.

For the twelfth time in succession, Swissmedic, the Swiss authority for the authorisation and monitoring of therapeutic products, and the Swiss pharmaceutical industry associations (ASSGP, Intergenerika, Interpharma, scienceindustries and vips) have conducted a benchmarking study analysing the times required to authorise human medicinal products in Switzerland and comparing them with the equivalent times for the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The results provide a factual basis for the ongoing dialogue between Swissmedic and the pharmaceutical industry. They help identify and implement improvements in the authorisation processes for human medicinal products.

The analysis is based on new applications for new active substances (NA NAS), additional indications (AIs), extensions and procedures for known active substances (KAS). The analysis of the throughput times in Switzerland considered all completed applications with a positive decision in 2024 (NA NAS: n=46, AIs: n=70, KAS: n=118, extensions: n=23). The data for the Swiss procedures originate directly from Swissmedic and cover 100% of the applications completed in 2024. The applications included in the study for the international comparison of the authorisation times for Swissmedic, the EMA and FDA were obtained directly from the participating companies and comprise 47.9% of the applications submitted to Swissmedic in 2024 (n=127).

Compared with the previous year, throughput times for Swissmedic authorisation procedures followed divergent trends:

Across all procedures, there were no major changes in NA NAS applications compared to the previous year. The only minor change was a longer throughput time for the NA NAS applications in the procedure according to Art. 13 TPA. By contrast, the throughput time for AI applications was 10% shorter compared to 2023.

The EMA was 7% faster than Swissmedic for NA NAS (all procedures) and 16% faster for AI applications (all procedures). The FDA remained significantly faster than Swissmedic: throughput times were 45% shorter for NA NAS (all procedures) and 41% shorter for AIs (all procedures).

Overall, both the submission gap and the approval gap for NA NAS between Swissmedic and the EMA narrowed year-on-year. In the comparison with the FDA, the submission gap was wider and the approval gap narrower compared to 2023. For the AI applications, the submission gap widened against both the EMA and the FDA year-on-year, although the approval gap against both reference authorities was narrower.

As regards known active substances, the throughput times for KAS without innovation (generics) in the standard procedure were slightly longer than in the EU. Throughput times for cases where the procedure under Art. 13 TPA was applied were shortened compared with the standard procedure.

In the labelling phase, the percentage of applications with text review rounds was virtually unchanged, at 29%, compared to the previous year.

Other trends and findings from the study can be found in the Executive Summary

In connection with the latest benchmarking study, Swissmedic refers to the "R&D Briefing 101" recently published by the Centre for Innovation in Regulatory Science (CIRS). This publication compares the authorisation times of six leading regulatory authorities – Swissmedic, EMA, FDA, PMDA, Health Canada and TGA – during the period 2015–2024.

Comparing this study with the "R&D Briefing 101", it should be noted that different inclusion criteria were used for the analysed applications, which may lead to differences in the key figures. However, similar trends are apparent: Swissmedic has stable throughput times and is ranked as a competitive regulatory authority in the international comparison.