This page provides information on the authorisation procedure at Swissmedic for clinical trials. All requirements for a complete application for the authorisation of a clinical trial can be found in the guidelines listed below.
Since 1 January 2014, applications for clinical trials in categories B and C can be submitted in parallel to Swissmedic and to the responsible Ethics Committee (clinical trials with therapeutic products in category A are exempt from Swissmedic's authorisation requirement – see Art. 30 ClinO, SR 810.305). Both authorities examine the respective dossier and issue separate approvals. The trial cannot be started until both approvals have been obtained (Art. 45 HRA, SR 810.30; Art. 54 HRA 812.21).
From 1 November 2024, the application must be submitted to the second authorising authority within two years after authorisation has been granted by the first authority. (Art. 23 para. 1bis – 1quater ClinO). At the request of the authorisation holder, the first authority may extend this deadline. Such an application is considered to be a substantial change to the clinical trial.
If these deadlines are exceeded, or if an application for an extension of the deadline is rejected, the granted authorisation lapses.
For information on reduced fees for academic clinical trials without commercial third-party funding, please refer to: Submission of applications