Clinical Trial Application

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

From 1 July 2025, expedited processing can be requested for clinical trial applications that meet certain criteria. The fast-track pilot project aims to significantly reduce the processing times for applications for clinical trials with medicinal products under certain conditions.

At least one of the following criteria must be met:

  1. High medical need: Trials addressing therapies for serious or life-threatening diseases for which there are no authorised treatment options in Switzerland.
  2. 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.

Applications for ‘high medical need’ must be submitted to Swissmedic in advance for preassessment. Further information on submitting fast track applications can be found under Submission of applications.

New implementing regulations apply as of 1 November 2024

The Federal Council approved the amendments to the ordinances relating to the Human Research Act (HRA) and adopted them on 7 June 2024. The amendments strengthen the protection of persons participating in research and, where possible, improve the regulatory framework for researchers. The amended ordinances came into force on 1 November 2024, with the exception of the provisions on transparency, which came into force on 1 March 2025.

On 16 September 2024, Swissmedic published instructions for applicants. See section "Implementation of new ordinances".

https://www.swissmedic.ch/content/swissmedic/en/home/humanarzneimittel/clinical-trials/clinical-trials-on-medicinal-products/clinical-trial-application.html