Fast-track project to expedite the processing of applications for clinical trials – pilot phase to start on May 1st, 2026
01.05.2026
swissethics is pleased to announce that starting May 1st, 2026, the ethics committees will enroll the fast-track pilot project that was initiated by Swissmedic in July 2025.
The fast-track pilot project aims to significantly reduce the processing times for applications for clinical trials with medicinal products. 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.
If the applicant has obtained the written confirmation from Swissmedic that the clinical trial is eligible for the fast-track procedure, then the applicant should submit the written confirmation with the first application to the competent ethics committee in BASEC. The ethics committee, and in case of a multicentric trial, the local ethics committees, will then review the trial as a priority.
Further information to obtain written confirmation from Swissmedic can be found here.