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)

https://www.swissmedic.ch/content/swissmedic/en/home/humanarzneimittel/clinical-trials/klinische-versuche-mit-arzneimitteln/fragen-und-antworten-und-wichtige-links.html