Faster processing of applications for clinical trials

With its fast-track procedure, from July 2025 Swissmedic is setting new standards for clinical trials in Switzerland. This method refers to the accelerated processing of initial applications and ensures that innovative treatments reach patients sooner without compromising on safety.

Switzerland is one of the leading research locations for clinical trials. In order to consolidate this position, Swissmedic is introducing the fast-track procedure as a pilot project. Under certain conditions, applications for clinical trials with medicinal products can be processed much faster. The aim is to promote innovation and ensure that patients have faster access to new, potentially life-saving treatments.

The core of the fast-track procedure is the prioritisation of studies with medicines for which a high medical need exists. This is the case if there is no authorised treatment option in Switzerland for a particular disease. The processing of trials in which known investigational medicinal products are to be tested will also be fast-tracked. In these cases, Swissmedic will significantly shorten the processing time for applications: Instead of the existing 30 days, the review will now only take 20 days. For trials in which a new active substance or a new type of treatment is to be tested in humans for the first time (known as first-in-human studies), the review period will be reduced from 60 to 40 days. This will clearly place Switzerland in the forefront compared to other countries: in the EU, a comparable procedure often takes more than 50 days.

Safety always takes precedence

Despite the accelerated procedures at Swissmedic, ensuring the safety of study participants remains the top priority. All regulatory requirements will still be met with the fast-track procedure.

The fast-track pilot project will initially run until the end of 2026. Since the legal basis for a permanent introduction is not yet in place, the project is being implemented as a pilot. A legal amendment to establish the procedure on a permanent basis may be possible in 2027 at the earliest. Until then, pharmaceutical companies, research and healthcare institutions will benefit from the shorter processing periods since it will enable clinical trials to be initiated more efficiently and innovative treatments to be made available sooner.

With its fast-track procedure, Swissmedic will strengthen Switzerland's position as a place for research, promote innovation and help patients profit from new medical options at an early stage. Just last year Swissmedic reduced its fees for processing applications for non-commercially funded clinical trials by 80 percent.