Benchmarking study 2025

In 2025, Swissmedic authorised 40 new active substances (NA NAS) and 109 additional indications (AI), as well as numerous known active substances (KAS) with and without innovation, and extensions for new dosage forms. Swissmedic underscores its competitiveness with throughput times for NA NAS authorisation applications falling between those of the FDA and the EMA.

For the thirteenth 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 exploit the potential for improvements in the authorisation processes for human medicinal products.

The analysis is based on new applications for new active substances (NA NAS), known active substances (KAS), and biosimilars, as well as additional indications (AIs) and extensions for new dosage forms. The analysis of the throughput times (time between the date of submission and the date of authorisation) in Switzerland considered all completed applications with a positive decision in 2025 (NA NAS: n=40, AIs: n=109, KAS: n=150, extensions: n=28, biosimilars: n=24). The data for the Swiss procedures originate directly from Swissmedic. The NA NAS data for the international comparison of the authorisation times were obtained from Swissmedic's own databases and public sources of the EMA and FDA. The AI data from the EMA and FDA were provided by the participating companies and matched to the Swissmedic data.

Half of all NA NAS in 2025 were authorised in an accelerated authorisation procedure, compared to 29% of AIs. The median national throughput time across all procedures for the NA NAS (n=40) was 392 calendar days (CDs), 12% shorter than in 2024, while the corresponding time for AIs (n=109) was 331 CDs (+4%).

Compared with the previous year, throughput times for Swissmedic authorisation procedures followed divergent trends: Whereas NA NAS in procedures with standard time limits (standard procedure and procedure according to Art. 13 TPA) were authorised slightly faster than in the previous year, the throughput time was slightly longer for the accelerated procedures (pooled). The throughput time for AIs under the standard procedure and the Orbis Type A procedure was slightly longer compared to 2024, while the time was slightly shorter for applications under Art. 13 TPA and in the Access procedure.

Internationally, the Swiss throughput time for NA NAS (all procedures, 392 CDs, n=40) was 7% shorter compared to the EMA (420 CDs, n=38) and 47% longer compared to the FDA (266 CDs, n=36). For AIs (all procedures, 331 CDs, n=109), the Swissmedic throughput time was 7% longer compared to the EMA (309 CDs, n=64) and 81% longer compared to the FDA (183 CDs, n=59).

The submission gap for NA NAS continued to widen in 2025 (all procedures): Compared to the EMA, the gap was 362 CDs (n=38, +61%) and therefore almost as wide as the submission gap of 405 CDs (n=36, +25%) compared to the FDA. The approval gaps were 212 CDs (EMA: -3%) and 485 CDs (FDA: +45%).

For AIs, the submission and approval gaps (all procedures) grew wider since 2024 compared to both the EMA and the FDA: compared to the EMA the submission gap was 93 CDs (n=64) and therefore almost half as wide as in the previous year (-49%); compared to the FDA the submission gap was 142 CDs (-37%, n=59). The approval gaps were 137 CDs (EMA: -33%) and 304 CDs (FDA: -20%).

In 2025, 20% and 52% more new applications, respectively, were authorised for KAS without innovation (n=109) and KAS with innovation (n=41) compared to the previous year. The throughput times for applications under Art. 13 TPA for KAS without innovation and KAS with innovation were 33% and 17% shorter, respectively, than those employing the standard procedure.

Across all application types, the percentage of applications subject to a formal objection rose from 43% to 47%, whereas the percentage of applications requiring a text review letter fell from 29% to 20%.

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 106" recently published by the Centre for Innovation in Regulatory Science (CIRS). This publication compares the authorisation times for new applications for new active substances of six leading regulatory authorities – Swissmedic, EMA, FDA, PMDA, Health Canada and TGA – during the period 2016–2025.

Comparing this study with the "R&D Briefing 106", it should be noted that different inclusion criteria were used for the analysed applications, which may lead to differences in the key figures. Nevertheless, the analyses paint a consistent picture: With stable throughput times, Swissmedic maintains its competitive position among the regulatory authorities included in the international comparison, thereby contributing to the rapid availability of medicines for the Swiss population.