Applicable laws and guidelines

New implementing regulations apply as of 1 November 2024

The Federal Council approved the amendments to the ordinances relating to the Human Research Act (HRA) and adopted them on 7 June 2024. The amendments strengthen the protection of persons participating in research and, where possible, improve the regulatory framework for researchers. The amended ordinances enter into force on 1 November 2024, with the exception of the provisions on transparency, which enter into force on 1 March 2025.

On 16 September 2024, Swissmedic published instructions for applicants. See section "Implementation of new ordinances".

https://www.swissmedic.ch/content/swissmedic/en/home/humanarzneimittel/clinical-trials/clinical-trials-on-medicinal-products/applicable-laws-and-guidelines.html