6 July 2026

Swissmedic published the results of the latest study by the Centre for Innovation in Regulatory Science (CIRS) on approval times for new active substances between 2016 and 2025. The study confirmed that Swissmedic remained among the fastest major regulatory authorities worldwide and continued to contribute to the timely availability of innovative medicinal products in Switzerland.

According to the study, Swissmedic approved 40 human medicinal products containing new active substances in 2025, of which 34 were included in the CIRS analysis. Swissmedic ranked ahead of the European Medicines Agency (EMA) in terms of overall approval time (413 days compared with 448 days) and ranked second globally for scientific assessment time. The study also found that Swissmedic frequently used facilitated review pathways with 68% of applications between 2021 and 2025. The study further highlighted that for products approved by Swissmedic in 2025, the median period between the first submission to any reference authority and the submission to Swissmedic amounted to 569 days, indicating that companies' submission strategies remained a significant factor affecting the timing of market access in Switzerland.

For more information, see here.