Clinical trials are scientifically controlled studies undertaken in humans to establish or confirm the safety and effectiveness of investigational medicinal products (IMPs). Clinical trials in the EU are governed by theClinical Trials Regulation, which became effective on 31 January 2022.
EC Clinical Trials · September 21, 2025
Key guidance documents for the Clinical Trials Regulation
Guidance documents supporting the Clinical Trials Regulation, which governs investigational medicinal product trials in the EU.
Applies from
2022-01-31
Published by EC Clinical Trials. HealthSignal links to the original document; the summary above is extracted from the source text.