The question of access times to innovative treatments has already caused a lot of ink, especially on the side of the pharmaceutical industry, which requires faster procedures. But where is Switzerland really in this area, compared to other major international agencies? The latest report of Centre for Innovation in Regulatory Science (CIRS)independent institution based in London, sheds encrypted and comparison.
This document examines the marketing authorizations of new active substances (NAS) in 2024, issued by six major regulatory agencies: FDA (USA), EMA (Europe), PMDA (Japan), Health Canada, TGA (Australia) and Swissmedic (Switzerland).
Sometimes in second place … sometimes at the last
Swissmedic claims to be at the same level as the EMA in matters of median permission time. The CIRS figures, however, nuance this assertion: the Swiss agency ended last, with 444 days, two weeks more than the EMA and 154 days more than the Japanese PMDA.
Median authorization time for new active substances (2015-2024)
In detail, Swissmedic, however, obtains more satisfactory results: it ranks second for the duration of the scientific examination, just behind the PMDA. One way of recalling that other factors come into play, such as the speed of industrialists to respond to the additional files requested.
Access to slowed down innovation?
Another sensitive point for industry: the attractiveness of the Swiss market. The CIRS shows that Swissmedic is the penultimate agency where companies submit their files first. The FDA and the EMA come widely in mind. As for companies outside Top 20 in R&D, they wait even longer to submit their requests to Swissmedic, with a median delay of 553 days.
Acceleration reigns (almost) everywhere
In 2024, accelerated examination procedures were used for 59% of files at the FDA, 34% at PMDA, 29% in Canada, 22% at Swissmedic, and only 9% at TGA. EMA, it did not appeal to it this year.
Swissmedic can, however, boast of the greatest difference in duration between standard and accelerated procedures: a gain of 210 days. And among the 46 requests it approved in 2024, eight was via highly accelerated tracks, for serious illnesses without alternative treatment.
Orbis collaboration projects (coordinated by the FDA for oncological treatments) and Access Consortium (bringing together Canada, Australia, Singapore, the United Kingdom and Switzerland) also allowed Swissmedic to reduce its deadlines by around 100 days.
And after authorization?
Swissmedic’s green light is only the beginning. Deadlines linked to the fixing of prices by the OFSP and the care by sickness insurance remain another source of tension with the pharmaceutical industry.
In summary, Swissmedic seems to be neither champion nor large last. If its global deadlines react, the speed of its scientific assessment, its international cooperation and its increased appeal to flexible procedures to qualify criticism.
