Last updated: 1 July 2025
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Switzerland is considered a leading research locations for clinical trials.
- To further expand this position, Swissmedic is introducing the fast-track procedure as a pilot project.
- Applications for clinical trials of medicines will be processed significantly faster under certain conditions.
- The goal is to promote innovation and provide patients with faster access to new, potentially life-saving therapies and strengthen Switzerland’s position as a research location.
What is at the core of the fast-track procedure?
At the core of the fast-track procedure will be the prioritization of studies with medicinal products for which there is a high medical need. This is the case when there is no approved treatment option for a disease in Switzerland.
When will the pilot fast-track procedure commence and how long will it run?
- The fast-track procedure will commence on 1 July 2025 and run until the end of 2026.
- Since the legal basis for permanent implementation has not yet been established, the project will be implemented as a pilot.
What are the criteria under which applications for clinical trials of medicines will be processed significantly faster?
At least one of the following criteria must be met:
- High medical need: Trials addressing therapies for serious or life-threatening diseases for which there are no approved treatment options in Switzerland.
- Known investigational medicinal products: Clinical trials testing active substances, combinations of active substances or investigational products that have already been reviewed and authorised by Swissmedic in previous clinical trials in Switzerland.
Is fast-track processing limited only to initial applications for authorisation of a clinical trial?
Yes, fast-track processing is limited to initial applications for authorisation of a clinical trial with medicinal products. Applications for amendments are excluded from fast-track processing.
Which other clinical trials applications are also not eligible for fast-track processing?
The following applications are also not eligible for fast-track processing:
- Clinical trials without medicinal products (medical devices, advanced therapy medicinal products, complementary and herbal medicinal products, other clinical trials)
- Complex clinical trials
- Combined trials of medicinal products and medical devices/in vitro diagnostic devices
- Radiopharmaceuticals
- Temporary authorisations
Registration as a fast-track application
1) Applications for high medical need
The applicationsmust be submitted for preassessment with Swissmedic for review of the criteria.
Preassessment procedure:
a) Complete the application form: Application Form Fast Track (DOCX, 372 kB, 01.07.2025)
b) Submit the accompanying letter and protocol synopsis together with the application form as follows:
i. By post: CD/DVD with the documents in the eDok folder structure, application form under 00F
ii. Portal: Portal zip file with the documents in the eDok folder structure, application form under 00F
Submission as new delivery – Case type = application for new case/authorisation
- During the preassessment, Swissmedic will check whether the criterion of ‘high medical need’ is met.
- Once this has been completed, Swissmedic forwards its decision (confirmation as fast track or rejection) to the applicant, who can then submit the actual application as a new clinical trial in the usual manner.
2. Applications for known investigational medicinal products
The applications can be submitted as normal, without advance submission for preassessment.
a. Complete the application form: Application Form Fast Track (DOCX, 372 kB, 01.07.2025)
b. Submit the application as normal as a new clinical trial. File the Fast Track application form under 00F, in addition to the KLV application form
c. Upon receipt of the application, Swissmedic will check whether the criterion of ‘known investigational medicinal product’ is met during the formal review.
How will the fast-track procedure impact review times for clinical trial applications?
i) Studies for known investigational medicinal products
Studies in which known investigational medicinal products are to be tested will also be processed faster.
- In these cases, Swissmedic will significantly shorten the processing time for applications.
- Instead of the current 30 days, the review will take just 20 days.
ii) Studies for which a new active ingredient or a new form of therapy is tested on humans for the first time (so-called first-in-human studies)
For studies in which a new active ingredient or a new form of therapy is tested on humans for the first time (so-called first-in-human studies), the review period will be reduced from 60 days to 40 days.
How is it expected that reduced assessment times for clinical trials applications will impact Switzerland when compared with other countries?
It is expected that this will put Switzerland at the forefront in international comparison. In the EU, a comparable procedure often takes more than 50 days
Will the fast-track procedure impact study participants or regulatory requirements in any way?
No, ensuring the safety of study participants will continue to remain a top priority. All regulatory requirements will be met.
Are the shortened deadlines in the fast-track procedure legally binding?
The shortened deadlines in the fast-track procedure are not legally binding, but represent a performance promise by Swissmedic. Swissmedic will make every effort to meet these deadlines, but delays may occur in exceptional cases.
When is it anticipated that a legal amendment will be made to the current legislation in order to establish the fast-track procedure permanently?
- A legal amendment to establish the procedure permanently could take place as early as 2027.
- Until then, pharmaceutical companies, research institutions, and hospitals will benefit from the shortened processing times, which will enable clinical trials to be initiated more efficiently and innovative therapies to be brought into healthcare more quickly.
Source:
Faster processing of clinical trial applications (Swissmedic) ;
Swissmedic, Submission of applications (Swissmedic)