International study on authorisation times confirms Swissmedic's competitiveness
Bern, 06.08.2025 — The speed with which regulatory authorities are able to make scientifically sound decisions on applications for the authorisation of innovative medicines is crucially important both for the industry and for patients. At the international level, Swissmedic is keeping pace with other leading regulatory authorities. Each year, the Centre for Innovation in Regulatory Science (CIRS) analyses the time taken by six authorities worldwide to authorise innovative medicinal products with new active substances. According to the latest “R&D Briefing 101”, Swissmedic remains one of the most efficient regulatory authorities, ranked second behind Japan in scientific assessment time and on a par with the EMA in terms of total throughout time. During the period under review, a large proportion of applications were processed under fast-track or internationally coordinated procedures such as Project Orbis or the Access Consortium, resulting in significantly shorter approval times.