International study on authorisation times confirms Swissmedic's competitiveness

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.

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 annually published study "R&D Briefing" compares the authorisation processes for innovative medicines with new active substances of six major authorities: EMA, FDA, PMDA, Health Canada, TGA and Swissmedic.

These are the key findings of the latest study "R&D Briefing 101: New drug approvals in six major authorities 2015–2024":

• The total throughput time for applications (Swissmedic and company time, including formal reviews and labelling after a preliminary decision of approval) was 444 days for Swissmedic, on a par with the EMA.
• As regards the scientific assessment time (core scientific assessment including company time for responding to questions), Swissmedic ranks second at 288 days, just behind the Japanese regulatory authority. This demonstrates the efficient working methods of both Swissmedic and the applicants in reviewing scientific documentation respectively 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.
• In 2024, Swissmedic authorised 46 applications for new active substances^[1], 37 of which were included in the CIRS study. Measured by quantity, the Swiss Agency for Therapeutic Products ranks third behind the US FDA and the Japanese regulatory authority.
• Between 2020 and 2024, Swissmedic applied at least one simplified procedure (Facilitated Review Pathway), including fast-track procedures, reliance procedures (Swissmedic can base all or part of its scientific assessment on decisions made by other trustworthy regulatory authorities) 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 leading authorities internationally in terms of the use of simplified procedures – directly behind the FDA (75 percent) and ahead of the TGA (63 percent), Health Canada (53 percent) and the EMA and PMDA (both 37 percent).
  • Project Orbis
    In this initiative characterised by close scientific collaboration, cancer drugs are reviewed concurrently by several authorities affiliated with the project under the leadership of the FDA. The total throughput time for Orbis applications is just 329 days, which is more than 100 days faster 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 exchanged, thereby making the regulatory systems more efficient. The total throughput time for applications within the Access Consortium is just 328 days, which is likewise more than 100 days faster than for applications as a whole.
• During the analysis period, Swissmedic approved eight applications in highly accelerated procedures (fast-track and temporary authorisation procedures) for medicines for life-threatening diseases with unmet medical needs.

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

• Optimal regulatory framework
  With average authorisation times of around 250 days, 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 data confirm Swissmedic's strategic focus on making innovations available quickly and safely. At the same time, this international comparison shows that the challenges facing medicinal product regulation are increasing globally – and that Swissmedic is successfully responding to this changing scenario.

^[1] _{Authorisations of human medicinal products with a new active substance and additional indications 2024}