Switzerland Aligns with the EU CTR

A critical appraisal of the Swiss Federal Act on Research involving Human Beings (Human Research Act, HRA) and associated Ordinances conducted in 2019 revealed, among others, that Switzerland might lose attractiveness for clinical trial conduct if it did not align with the international legislation, in particular with the EU Clinical Trials Regulation (Reg. (EU) No. 536/2014, also known as the EU CTR).

Following this analysis, the Swiss authorities have made revisions to the four Ordinances to promote transparency, to harmonise the requirements for sponsors and to keep up with digitalisation advancements like e-consent. The revised legal texts have been published on 7 June 2024.

Looking at the clinical trials framework, among the EU CTR concepts that have been adopted in the Clinical Research Ordinance (ClinO) are the following:

• Increased transparency in publishing clinical trials and posting a summary of results within 1 year from the end of trial
• Reporting of key study milestones like the start and end of trial, early termination and trial restart
• Safety reporting requirements and timelines
• The expiry of the trial authorisation if no participant is included within 2 years
• The longer archiving period for clinical trial master file, albeit only for 20 years as opposed to 25 years under the EU CTR.

What has not been taken over from the EU CTR are the following aspects, that have posed difficulties to sponsors and investigators so far:

• The notoriously tight deadlines to respond to Requests for Information (RFIs) in relation to clinical trial applications
• The reporting timelines for the milestones above, which will be 30 days under the ClinO.

Other changes include the openness towards and clarity around the requirements for e-consent or the redefinition of research categories (A, B and C).

The transitional provisions are staggered and complex, reminding us again of the EU CTR. For example, the reporting requirements become applicable as early as 1 November 2024, however they are optional until 31 October 2025. The publishing of the summary of results within 1 year of completing the trial under ClinO is applicable from 1 March 2025.

Further guidance, templates and exact list of required documents for submission are expected from the Swissmedic and swissethics later on.