As of January 31, 2022, new regulations for clinical trials of medicinal products came into force in the EU/EEA area. This change does not directly affect the conduct of clinical trials with medicinal products in Switzerland.
Even after January 31, 2022, the Clinical Trials Ordinance (ClinO, SR 810.305) will apply to the conduct of clinical trials with medicinal products in Switzerland. Applications must continue to be submitted via the existing information systems of the Swiss enforcement authorities - cantonal ethics committees and Swissmedic.
In the European Union and the European Economic Area (EU/EEA area), clinical trials are uniformly regulated by Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use from January 31, 2022. This regulation has replaced the existing Directive 2001/20/EC. Regulation (EU) No. 536/2014 was already adopted by the EU Parliament on April 16, 2014, but due to delays in the technical implementation of the electronic portal "Clinical Trial Information System" (CTIS), came into force only almost 8 years later. Regulation (EU) No. 536/2014 harmonizes the authorization procedure within the EU.
The FOPH has always closely followed developments regarding the implementation of the Regulation within the EU and its member states. From 2014 to 2019 and also for the period from August 2022 up until 2025, the SFL-Services company has been reporting regularly to the FOPH on this subject. The reports are written in English and can be downloaded below under "Documents".
In the context of the revision of the ordinance law on the Human Research Act, selective adaptations to the EU regulations are being examined.
Comparison of Swiss and EU legislation
Christoph A. Zenger compared the Swiss federal legislation on human research and Regulation (EU) No. 536/2014 on behalf of the Federal Office of Public Health (FOPH) in 2014. His report was published in German with a summary in French, Italian and English. The report and the summary can be accessed under “Documents”.
Study on the impact of the EU regulation on clinical trials with medicinal products for human use on Switzerland
Following the jurisprudential comparison between Regulation (EU) No. 536/2014 and the current Swiss legislation on human research, the FOPH had commissioned a multidisciplinary study to investigate the possible implications for Switzerland of the EU Regulation following its implementation. This was published in March 2019. The economic relevance of drug research first had to be established so that the possible legal challenges could then be highlighted – for example, the need to ascertain the views of stakeholders and their expectations regarding the legislation. The study was conducted by a consortium headed by Prof. Michael Hahn from the Institute of European and International Economic Law at the University of Bern (IEW). The report was published in German with a summary in French, Italian and English. The report and the summary can be accessed under “Documents”.
Documents
- Executive summary-implications for Switzerland of Regulation (EU) on Clinical Trials on Medicinal Products (PDF, 156 kB, 28.02.2019)
- Schlussbericht: Auswirkungen der VO 536/2014 über klinische Prüfungen mit Humanarzneimitteln (only in German) (PDF, 1 MB, 26.03.2019)
- Report by C.A. Zenger (only in German) (PDF, 922 kB, 28.11.2016)Comparison between the Swiss federal human research act and implementing ordinances and the EU regulation of 16 April 2014 (CTR) on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
- Table comparing Clinical Trials Ordinance (ClinO) and CTR (only in German) (PDF, 722 kB, 28.11.2016)
Legislation
Last modification 20.12.2023
Contact
Federal Office of Public Health FOPH
Division of Biomedicine
Human Research Section
Schwarzenburgstrasse 157
3003
Bern
Switzerland
Tel.
+41 58 463 51 54