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

02.09.2021

New VO form and new format for authorisation applications plus changes/notifications/reports regarding clinical trials with medicinal products as of 13 September 2021

From 13 September 2021, applications must be submitted using a new folder structure (“eDoc” structure), a new application form (“VO form”), and to a new address for submissions. Important: only formal aspects change, the legal requirements remain the same.

These changes will be introduced as a key element in preparing for a paperless (i.e. electronic) submission procedure. However, purely paperless submissions will not yet be possible as of 13 September 2021 but will only be implemented at a later date. As hitherto, therefore, you will still have to make submissions on paper and on CD even after 13 September 2021, confirming with your (wet-ink) signature that the files on the CD are identical with the paper documents (exact same wording).

All the documents and instructions you need for the new procedure are now available for download:

As of 13 September 2021, any submissions according to the old submission procedure will be deemed to be formally deficient.

If you have any questions, please send them to: ct.medicinalproducts@swissmedic.ch

Many thanks for noting this information.


09.09.2021

Position paper by Swissmedic and swissethics on decentralized clinical trials (DCTs) with medicinal products

The development of novel technologies and digitalization in the field of therapeutic products offers new opportunities. Through the use of these technologies in clinical trials, it is possible that study visits do not always have to be carried out in the hospital, but can also take place at home. In this context, innovative technologies allow health-related data to be digitally recorded and transmitted via devices worn on the body. These special features and other aspects play an essential role in so-called decentralized clinical trials (DCTs).

This development poses new challenges for all those involved. In a position paper, Swissmedic and swissethics have summarized the main current challenges of DCTs with medicinal products and show under which conditions such clinical trials could be conducted in Switzerland. The paper is addressed to researchers and sponsors as well as all those interested in clinical research.