Swissmedic, the Swiss Agency for Therapeutic Products, authorized 46 human medicinal products with new active substances for the Swiss market in 2024, marking a 12% increase from the 41 approvals granted in the previous year. This growth represents a continued recovery in new drug approvals following the pandemic period when COVID-19-related applications took priority over other innovative medicines.
Authorization Procedures and Regulatory Framework
The 2024 approvals utilized multiple regulatory pathways, including the reliance procedure, fast-track procedure, and international procedures under Access and Orbis frameworks. These diverse authorization mechanisms demonstrate Swissmedic's commitment to providing multiple avenues for bringing innovative therapies to Swiss patients while maintaining rigorous safety and efficacy standards.
The agency's comprehensive report summarizes the most important information on these new authorizations as well as approved additional indications, providing stakeholders with detailed insights into the duration of procedures and therapeutic areas covered.
International Benchmarking Initiative
Swissmedic is actively participating in two benchmarking studies conducting international analysis of authorization times with leading partner authorities. These comparative studies aim to evaluate the agency's performance against global regulatory standards and identify opportunities for process optimization. The findings from these benchmarking initiatives will be published during 2025, providing transparency into Switzerland's regulatory efficiency relative to other major markets.
Historical Context and Pandemic Impact
The current approval numbers reflect a normalization following the pandemic period's unique challenges. During 2020-2021, Swissmedic prioritized applications for medicines and vaccines against SARS-CoV-2, which affected the processing timeline for other innovative new applications. The increased review times observed in 2022 were primarily attributable to applications submitted and processed during these intensive pandemic years.
Despite these challenges, Swissmedic maintained strong performance throughout the pandemic period, assessing record numbers of medicinal products with new active substances in both 2020 and 2021. The agency's ability to handle extraordinary pandemic workload while continuing to evaluate innovative therapies demonstrates the robustness of Switzerland's regulatory infrastructure.
Regulatory Performance Metrics
The 2024 data represents part of Swissmedic's ongoing commitment to transparency in regulatory performance. The agency's detailed reporting includes comprehensive information on procedure types, duration of authorization processes, and therapeutic indications, enabling industry stakeholders to better understand regulatory timelines and requirements for market access in Switzerland.
