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

15.06.2021

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 (“eDOK” structure), a new application form (“VO form”), and to a new address for submissions

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).

By way of example, we are providing an image of the file structure valid as of 13 September 2021 (see screenshot). Please note that this is for information purposes only.

On 13 September 2021 the new VO form and the new eDOK folder structure will be ready for downloading from our website together with detailed instructions on the new procedure for sponsors.

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

Summary:

  • Until 12 September 2021 the submission procedure remains unchanged
  • As of 13 September the following changes apply:
    • New VO form
    • New folder structure
    • New address for submissions

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

Many thanks for noting this information.