Swissmedic publishes 2024 benchmarking study on drug authorisation times
The Swiss Agency for Therapeutic Products (Swissmedic) has published its 12th annual benchmarking study, comparing its drug authorisation times with the European Medicines Agency (EMA) and US Food and Drug Administration (FDA). The study assessed throughput times for completed applications with positive decisions in 2024, covering 46 NASs, 70 additional indications, 118 known active substances, and 23 extensions. Data for Swissmedic procedures were sourced directly from the authority, while international comparisons were based on 127 applications submitted to Swissmedic, representing 47.9% of the total. Swissmedic’s throughput times for NASs remained stable compared to 2023, with a slight increase observed in applications processed under Article 13 of the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA). Throughput times for additional indications decreased by 10%.