CIRS study on authorisation times for human medicinal products with new active substances confirms Swissmedic’s competitiveness internationally

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.

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 %).
  • Project Orbis
    Cancer drugs are reviewed concurrently by several authorities affiliated with the project under the leadership of the FDA. This initiative is characterised by close scientific collaboration. The total throughput time for Orbis applications in 2025 was just 321 days, which was almost 100 days shorter than for applications as a whole.
  • Access Consortium
    This joint initiative of like-minded medium-sized drug regulatory authorities (Canada, Australia, Singapore, United Kingdom, Switzerland) allows the review workload to be shared among the participating regulatory authorities, synergies to be exploited and knowledge to be shared, thereby making the regulatory systems more efficient. The total throughput time for applications within the Access Consortium in 2025 was 395 days.
• In 2025, Swissmedic approved 6 applications in highly accelerated procedures (fast-track and temporary authorisation procedures) for medicines for life-threatening diseases with unmet medical needs. The total throughput time for these applications in 2025 was just 285 days, which was more than 100 days shorter than for applications as a whole.
• At the same time, the analysis confirms that the availability of new medicines in Switzerland not only depends on the throughput times, but is also significantly influenced by the timing of application submission by the companies: For the new active substances authorised by Swissmedic in 2025, the median time between the submission to the first authority (reference authority; defined as the first authority to be addressed in each case, which can vary depending on the application) and submission to Swissmedic ("submission gap") was 569 days. Most applications were submitted to the FDA first, hence the lack of a submission gap for this authority, followed by the EMA with a gap of 69 days. The submission gaps were much wider for Health Canada (670 days), TGA (700 days) and PMDA (807 days).

Requirements for rapid market access
The following factors are crucial for rapid market access to new medicines:

• Early submission of authorisation applications by the industry
• Optimal regulatory framework
  Procedures such as temporary authorisation and fast-track authorisation make a significant contribution to the particularly rapid authorisation of medicines with high therapeutic benefit for life-threatening diseases.
• International cooperation
  Initiatives such as the Access Consortium and Project Orbis allow new active substances to be reviewed jointly, not only reducing authorisation times, but also encouraging the early submission of applications to Swissmedic.

The study results confirm Swissmedic’s strategic focus: making innovations available to patients quickly, safely and based on reliable scientific evidence. The international comparison also illustrates how the regulatory requirements for medicinal products are increasing worldwide. Swissmedic is responding to this trend with efficient procedures and the targeted refinement of its regulatory processes.

The full analysis is available on the CIRS website: «R&D Briefing 106».

_{[1] Lara J, Kermad A, Bujar M, McAuslane N. 2026. R&D Briefing 106: New drug approvals in six major authorities 2016-2025: Trends in an evolving regulatory landscape. Centre for Innovation in Regulatory Science. London, UK.}

_{[2] Authorisations of human medicinal products with a new active substance and additional indications 2025}

_{[3] Reliance procedures: Swissmedic can base all or part of its scientific assessment on official decisions made by countries with equivalent medicinal product control (authorisations according to Art. 13 TPA and Art. 14 para. 1 let. abis-quater TPA)}