The latest "R&D Briefing 106" shows that Swissmedic continues to achieve impressive results in the international arena and significantly contributes to the rapid availability of innovative medicines in Switzerland.
CIRS study on authorisation times for human medicinal products with new active substances confirms Swissmedic’s competitiveness internationally
International authorisation times for human medicinal products with new active substances during the period 2016–2025
Rapid and scientifically sound decisions on applications for the authorisation of innovative medicines are just as important for industry as they are for patients. Each year, the Centre for Innovation in Regulatory Science (CIRS) analyses the time taken by six regulatory authorities worldwide – Swissmedic, EMA, FDA, PMDA, Health Canada and TGA – to authorise innovative medicinal products. CIRS is an independent organisation based in London that specialises in the promotion of regulatory science. It seeks to define global standards for the authorisation of medicinal products and accelerate market access to medicines.
The latest study "R&D Briefing 106": New drug approvals by six major authorities 2016–2025: Trends in an evolving regulatory landscape"[1] shows the following results for Swissmedic in particular:
- In 2025, Swissmedic authorised 40 human medicinal products with new active substances for the Swiss market[2], 34 of which were included in the CIRS study.
- The total throughput time (Swissmedic and company time, including formal reviews and labelling after a preliminary decision of approval) was 413 days for Swissmedic in 2025, faster than the 448 days taken by the EMA.
- As regards the scientific assessment time on its own (core scientific assessment including company time for responding to questions), Swissmedic ranks second at 303 days, just behind the Japanese regulatory authority. This demonstrates the efficient working methods of both Swissmedic in reviewing scientific documentation and the applicants in responding to the "List of Questions" (LoQ). The LoQ is concerned with queries, concerns or requests for additional information that must be answered by the applicant before a medicinal product can be authorised.
- The measures taken by Swissmedic at the start of 2025 to optimise the labelling phase are producing tangible results: The length of the labelling phase has been shortened by 22 days to 119 days.
- Between 2021 and 2025, Swissmedic applied at least one simplified procedure (Facilitated Review Pathway) for 68 % of the applications. Such pathways include fast-track procedures, reliance procedures[3] or parallel assessments in cooperation with foreign partner authorities within the framework of Project Orbis or the Access Consortium. This means that Swissmedic is one of the authorities with the highest proportion of simplified procedures internationally, directly behind the FDA (75 %) and ahead of the TGA (62 %), Health Canada (55 %), PMDA (24 %) and EMA (36 %).
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