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
10.02.2025
Update of the position paper of Swissmedic and swissethics on decentralised clinical trials (DCTs) of medicinal products
The position paper has been comprehensively amended and updated (new version 3.1). New features include a comparison of Switzerland with European member states in terms of the feasibility of various DCT elements.
01.12.2024
Position paper by Swissmedic and swissethics on clinical trials with medicinal products examined for the first time in humans
During clinical trials with medicinal products in early development phases (i.e. first in human application, early phase I studies) new investigational medicinal products are examined for the first time in humans. Initial insights are hereby collected on their tolerability and safety. To ensure the protection of the trial participants to the greatest extent possible, special aspects have to be considered during the planning and conduct of such clinical trials by the sponsors and participating clinical trial centres. Swissmedic and swissethics have summarised these aspects in a position paper.
Combined studies: New forms and a new information sheet for submissions to Swissmedic
A clinical trial of medicinal products/advanced therapy medicinal products may be conducted in parallel with a clinical investigation of medical devices / an interventional performance study of in vitro diagnostics. In this case, requirements for the different types of research apply in full.
New forms and a new information sheet are now available to facilitate submissions to Swissmedic. Please also see our new website on combined studies:
For academic clinical trials without commercial third-party funding, a fee reduction in accordance with Art. 12 FeeO-Swissmedic may be requested as of 1 July 2024
Sponsors of clinical trials with medicinal products, medical devices and novel therapies that are not financed by commercial third-party funding now have the opportunity to apply for a fee reduction. Further information and application: Submission of applications
22.05.2024
No confirmation of receipt for reportings
For notifications (Reportings) submitted on paper (not via the KLV portal), Swissmedic will no longer send acknowledgements of receipt with immediate effect. Acknowledgement of the notification will continue to be confirmed by letter on completion of processing.
09.06.2023
Applications for clinical trials with medicinal products and ATMPs (advanced therapy medicinal products) can be submitted via portal from 19 June 2023
The development of the new eGov portal function for electronic submission of applications for clinical trials with medicinal products and ATMPs is in its final phase. The new application is currently being tested with selected participants in a pilot phase. From 19 June 2023, the new portal for clinical trials with medicinal products and ATMPs will be available to all sponsors, investigators, research institutions and their contractual partners for fully electronic submission of applications. Further information will be provided here.
Please note that a new version of the form (V2) together with the Quick Instruction have also been published on Swissmedic website. We kindly ask you from now on to use version 2 of the form.
30.04.2021
Please note:
As of May 1st, submissions concerning trials 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.
18.12.2020
Pandemic by SARS-CoV-2
The spread of the new coronavirus (SARS-CoV-2) also poses a major challenge for clinical trials of medicinal products in Switzerland. Swissmedic and swissethics have therefore published a joint document, which describes the most important recommendations for the treatment of patients in clinical trials of medicinal products.
Due to the ongoing pandemic, the chapter on "Monitoring” was revised. "Remote source data verification” of aspects critical for patient safety and data integrity is permitted under certain conditions within the framework of clinical trials with medicinal products in times of the pandemic. Adjustments have also been made to the submission process for reportings / applications due to the current situation. Details related to the amended submission process are outlined in the guidance paper.
08.12.2020
Guidance document on the use of food stuffs and food supplements in research
The guidance document of swissethics on the use of food stuffs and food supplements in research can be found on the swissethics website: Link
10.07.2019
23.11.2018
Art. 9b (new) Temporary authorisation for use and for restricted placing on the market
1 The Agency may, for a limited period of time, permit certain persons or a certain group of persons outside the scope of clinical trials to use medicinal products according to Article 9 paragraph 2 letter d.
The Guideline Amendments in Clinical Trials was revised in order to introduce the new form „VO Form Administrative Changes“. This new form includes the notification of changes concerning sponsorship, changes concerning the Swiss representative and other administrative changes. The updated version (version 6.0) of the Guideline Amendments in Clinical Trials and the new form “VO Form Administrative Changes” must be implemented as of 10.09.2018.
Reference Safety Information
As required in the Guideline “Clinical Trial Application Dossier”, sponsors must designate a Reference Safety Information (RSI) for all IMPs in a clinical trial. To clarify the requirements for RSIs, the Clinical Trial Facilitation Group CTFG) established by the Heads of Medicines Agency (HMA) has recently published an updated Question & Answer document on Reference Safety Information (November 2017). The Swissmedic Clinical Trial Division endorses this document and applies the same requirements for RSI in clinical trials in Switzerland.
A transition period of 1 year is granted as described in the Covering Note published by the CTFG in March 2018. All RSIs must follow these requirements by 1st January 2019.
Both the Q&A document and the covering note can be found under http://www.hma.eu/ctfg.html > Key document list > Clinical Trial Safety
A “” has to be submitted in each Clinical Trial Application. Please be aware that JavaScript must be activated when filling the form. If JavaScript is not active important functions of the form will not work and it will be filled incorrectly. This can trigger formal deficiencies or requests for further information delaying the evaluation of the CTA.
The Guideline Clinical Trial Application Dossier was revised in order to harmonise procedures for submission of quality and GMP documentation and to include additional information on import of products and on study drug reconstitution / preparation. The new version (version 03) of the Guideline Clinical Trial Application Dossier must be implemented as of 01.01.2017.