Speedy Switzerland
Why we often receive authorisation applications later
Research and innovation
Swissmedic is improving the framework conditions for clinical studies in Switzerland
Swissmedic is making it easier to conduct clinical studies in Switzerland by shortening procedures, simplifying administration and reducing fees. This improves planning efficiency and speeds up approval, but without compromising on quality and safety. In addition to research organisations, this will benefit patients, who will have earlier access to innovative treatments.
From left to right: Simona Berardi Vilei, Head of the GCP/GVP Inspectorate unit, Simone Ferbitz, Head of the Clinical Trials Division, Kirsten Leidreiter, Head of the Clinical Study Assessment unit.
Clinical studies are a core component of the development and testing of new medicinal products, advanced therapy medicinal products (ATMPs) and medical devices. Swissmedic is committed to ensuring that this research can take place in Switzerland under advantageous conditions.
The Clinical Trials (CT) Division works closely with the Advanced Therapy Medicinal Products (ATMP) and Medical Devices Clinical Investigations (MDCI) Divisions to make sure this is the case. Together they implement measures that improve the framework conditions for clinical research, such as fee reductions, fast-track approval procedures, simplified processes and advice on regulatory issues.
Reduced fees for non-commercial research
In July 2024, Swissmedic reduced the processing fees for clinical studies by academic institutions and independent research groups by 80 percent. Studies that do not have funding from pharmaceutical companies or the medtech industry qualify for the reduction. 64 studies are already taking advantage of this innovation.
"Non-commercial trials are vital. They provide independent scientific findings and often lay the foundations for new medical guidelines", says Simone Ferbitz, Head of the Clinical Trials Division. However, fees can be a particular barrier for academic researchers because apart from the flat-rate initial approval fee, costs are continually incurred for assessing safety reports, changes and other mandatory reporting.
Fast-track pilot project: Faster approval for promising treatments
Since mid-2025, Swissmedic has been piloting a fast-track assessment and approval procedure for clinical trials of medicinal products. The aim is to prioritise promising trials involving new treatment options and approve them faster, but without compromising on quality and safety. Fast-tracking will be used particularly when there is still no effective treatment for a particular disease (high medical need) or if Swissmedic is familiar with the trial medication and its active substance has been well researched. This is where fast-tracking reduces processing time substantially: Instead of 30 days it takes only 20 to assess such trials. For first-in-human trials, where new medicinal products are tested on people for first time, and new active substances, the assessment period is reduced from 60 to 40 days. Particularly careful assessment is essential here because the safety of participants has top priority.
"We're happy to advise at an early stage and ensure that the path is clear for efficient development of innovative medicinal products right from the outset".
"The faster trials are approved, the greater Switzerland's appeal as a centre of research, particularly compared with other countries", says Kirsten Leidreiter, Head of the Clinical Study Assessment unit. "Similar procedures often take more than 50 days in the EU, so we are significantly faster. That creates advantages for researchers and patients since new treatments are rolled out faster while safety remains consistently high".
Since there is currently no legal basis for a universal fast-track procedure, the pilot project is likely to continue until the end of 2026.
Combined trials: Simplified submission process
Trials that investigate medicinal products in combination with medical devices or diagnostics – say a medicine administered using a novel infusion pump – are becoming ever more common.
Swissmedic introduced a new submission procedure for these combined trials in early 2024. Researchers now have a central point of contact at Swissmedic which coordinates assessment by various Divisions.
This is an advantage internationally: Many countries have separate processes for trials that combine medicinal products with medical devices, often involving different authorities. In Switzerland, however, Swissmedic assesses both. These short, efficient processes benefit both the pharmaceutical and medtech sectors.
Extending advisory services: Promoting innovations
Since 2025, Swissmedic has been expanding its scientific and regulatory advisory services for clinical trials with the particular aim of supporting start-ups and academic institutions. In addition to the Innovation Office, which focuses on innovative treatments (ATMPs), advisory services are now available for trials involving conventional medicinal products. The aim is to identify regulatory obstacles early on, avoid errors and speed up approval processes. "We're happy to advise at an early stage and ensure that the path is clear for efficient development of innovative medicinal products right from the outset", says Simone Ferbitz. Thus Swissmedic is helping strengthen Switzerland as a research location and encourage the development of innovative medicinal products.
