Starting on 1 May 2026, ethics committees in Switzerland are enrolling in the fast-track pilot project initiated by Swissmedic in July 2025. The pilot aims to significantly reduce processing times for applications for clinical trials with medicinal products, ultimately enabling faster enrolment of participants into authoriaed trials.

To qualify for the fast-track procedure, at least one of the following criteria must be met:

• High medical need: The trial addresses therapies for serious or life-threatening diseases for which no approved treatment options currently exist in Switzerland.
• Known investigational medicinal products: The trial tests active substances, combinations of active substances, or investigational products that have already been reviewed and authorised by Swissmedic in previous clinical trials in Switzerland.

Applicants who have obtained written confirmation from Swissmedic that their clinical trial is eligible for the Fast-Track procedure should submit this confirmation alongside their first application to the competent ethics committee via the BASEC Portal. The ethics committee and, in the case of multicentric trials, the local ethics committees, will then review the trial as a priority.

Further information on how to obtain written confirmation from Swissmedic is available on the Swissmedic website. Additional details on the procedure can be found on the swissethics website.