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).
For information on reduced fees for academic clinical trials without commercial third-party funding, please refer to: Submission of applications