The EU Clinical Trial Regulation (EU-CTR) will apply to clinical trials on medicinal products in the EU/EEA from 31 January 2022. The ClinO will continue to apply unchanged in Switzerland.
- The legal provisions governing clinical trials on medicinal products for human use will change in the European Union and the European Economic Area (EU/EEA) from 31 January 2022. From this date, EU Regulation No. 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use (Clinical Trial Regulation EU-CTR) will apply.
- This change has no direct impact on the conduct of clinical trials with medicinal products in Switzerland, where the Clinical Trials Ordinance (ClinO, SR 810.305) will continue to apply.
- The existing electronic information systems operated by the Swiss enforcement authorities (cantonal ethics committees and Swissmedic where applicable) should continue to be used to submit applications for clinical trials on medicinal products in Switzerland.
- Some modifications in line with the EU-CTR will be considered when the implementing ordinances relating to the Human Research Act are revised.
You can find further information regarding the EU-CTR on the website of the Federal Office of Public Health (FOPH).