Clinical trials on medicinal products

This site and the enclosed links contain useful information for sponsors, investigators or research institutions conducting clinical trials with medicinal products in Switzerland. It provides clarifications concerning the submission of trial documentation and gives information about different aspects of the clinical trial process, with references to other relevant documents and useful internet sites.

The Clinical Trials Ordinance (ClinO, SR 810.305), implemented on 01.01.2014, introduces a clear division in responsibilities between Swissmedic and the Ethics Committees. To find more information about aspects of clinical trials that fall under the competence of the Ethics Committees (e.g. insurance), please refer to www.swissethics.ch.

Even though the information in this website is regularly updated, it is possible that it is not exhaustive. Swiss legislation and international standards, such as the Clinical Trials Ordinance (ClinO, SR 810.305), and the current versions of the ICH-GCP E6 and the Declaration of Helsinki always prevail in case of doubt or conflict.


Inhouse News

06.04.2021

Please note:

As of May 1st, clinical trial applications with IMP(s) and non-conforming MD(s) or MD(s) not used according to its CE marked instructions must be submitted to the division medical devices only. Information about the new submission requirements and changes to the authorization procedure concerning clinical trials with medical devices is available here

12.01.2021

Restricted phone availability – please write to us instead!

Due to the COVID-19 pandemic, Swissmedic is currently receiving more queries than usual. We are therefore unable to receive telephone enquiries. Please submit your questions to us by e-mail (ct.medicinalproducts@swissmedic.ch). Thank you for bearing with us.