Swissmedic authorised 40 human medicinal products with new active substances for the Swiss market in 2025. Overall, the median turnaround time was 392 calendar days, which is 52 calendar days (12%) faster than in the previous year. 25% of the new authorisations were processed in connection with international procedures.
Swissmedic also authorised 109 additional indications for human medicinal products with existing authorisations in 2025. This is an increase of 54% versus the previous year. 19% of the additional indications were also processed in connection with international procedures.
The report summarises the most important information on these new authorisations as well as on the approved additional indications. You can get an overview of the authorisation procedures used (including the reliance procedures, fast-track procedures and international procedures under Access and Orbis) as well as the duration of the procedures and indications in the flyer: