13 July 2026

Swissmedic has published the results of its annual Benchmarking Study 2025, comparing the authorisation timelines for human medicinal products in Switzerland with those of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The study found that the median throughput time for new active substance applications decreased by 12% to 392 calendar days in 2025, placing Swissmedic between the FDA (266 days) and the EMA (420 days). According to Swissmedic, the findings confirm the Agency's internationally competitive position while also identifying opportunities for further optimisation of authorisation procedures. The report further analyses approval timelines for additional indications, biosimilars, known active substances and extensions for new dosage forms, as well as trends relating to submission and approval gaps.

For more information, see here.