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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 came into force on 1 November 2024. The provisions on transparency will enter into force on 1 March 2025.

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