EU CTR Resource Hub
Your one-stop-shop to ensure regulatory compliance
Get all the latest news, learn best practices, and hear what strategies your peers are adopting to comply with the EMA Clinical Trials Regulation (CTR) that went into effect for all new studies on 31 January 2023.
Connect with a CTR expert

Resource Spotlight

Quick Links

The EMA Clinical Trials Regulation (CTR) aims to create an environment that is favorable to conducting clinical trials in the European Union (EU)/European Economic Area (EEA), with the highest standards of safety for participants and increased transparency of trial information.

Learn More

The regulation harmonises the assessment and supervision processes for clinical trials throughout Europe, via a Clinical Trials Information System (CTIS) – a centralised portal and database for clinical trials. CTIS is the entry point to submit all the required data for a clinical trial following CTR, and is the interface between Sponsors and Member States.

Learn More

Subscribe to the EMA CTIS newsletter for updates on CTIS usage, key facts, tips, and reference materials.

Subscribe Now