Q&A and important links

Below you will find answers to the frequently asked questions our Clinical Trial Division receives. Please do not hesitate to contact us, should you have a question that is not clarified in these documents, or in the other published guidelines and instructions.

Additional information can also be found in the external sites presented in the important links section below. You can refer to the Swissethics website (Swiss Association of Ethics Committees for Clinical Trials) for the aspects of clinical trial review that do not lie within the competence of Swissmedic according to the new Clinical Trials Ordinance, ClinO.

Q&A related to clinical trials with medicinal products


Instructions for clinical trials on medicinal products with a medical device component


Interpretation guide: Obligations of representatives of foreign sponsors


Important links

Federal Office of Public Health (FOPH / BAG) – Clinical trial Legislations (Information only in German, French or Italian)

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. The provisions on transparency will enter 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/q-a-and-important-links.html