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Clinical trials

Clinical trials are used to systematically gather information on medicinal products when used in humans. Swissmedic verifies whether the quality and safety of the test product is guaranteed. Clinical trials may only be carried out in Switzerland if they have been approved by an Ethics Committee and by Swissmedic.

Applicable laws

Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA; SR 812.21)

Federal Act on Research involving Human Beings (Human Research Act, HRA) (PDF, 158 kB, 29.12.2014)

Ordinance on Clinical Trials with the exception of Clinical Trials of Medical Devices (ClinO; SR 810.305)

Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO; SR 810.301)

Ordinance on Organisational Aspects of the Human Research Act (HRA Organisation Ordinance, OrgO-HRA) (PDF, 107 kB, 29.12.2014)

Erläuternder Bericht über die Verordnungen zum Humanforschungsgesetz (PDF, 513 kB, 21.08.2013)

Verordnung des Schweizerischen Heilmittelinstituts über seine Gebühren (GebV-Swissmedic; 812.214.5)

Ordinance on Licensing in the Medicinal Products Sector (Medicinal Products Licensing Ordinance, MPLO; SR 812.212.1)

Interpretation guide: Obligations of representatives of foreign sponsors (PDF, 66 kB, 22.04.2014)

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".

https://www.swissmedic.ch/content/swissmedic/en/home/humanarzneimittel/clinical-trials.html