Clinical trials on medicinal products for human use in the EU

As of January 31, 2022, new regulations for clinical trials of medicinal products will become effective 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 will be uniformly regulated by Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use from January 31, 2022. This replaces 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), it will enter into force almost 8 years later. Regulation (EU) No. 536/2014 harmonizes the authorization procedure within the EU.

The FOPH has always closely followed developments in the EU. Until the end of 2019, the company SFL-Services has regularly reported to the FOPH on this. 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”.

Last modification 18.01.2022

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