How The New EU Clinical Trials Regulation Will Impact Sites And Sponsors And How You Can Prepare

By Taylor Davidson, Florence Healthcare

The Clinical Trials Regulation (CTR) for the EU took effect on 31 January 2022. Sites and sponsors must now embrace the new regulations to successfully run clinical trials across the European Union. 

To help, the European Commission (EC), Heads of Medicines Agencies (HMA), and European Medicines Agency (EMA) came together to create the Accelerating Clinical Trials in the EU (ACT EU) Initiative. 

This initiative consists of 10 suggested actions for sites, sponsors, and CROs to take over the next three years, leading up to the full implementation deadline in January 2025. 

Here’s what we’ll cover in this article to help you get ready:

• The goals of the EU Clinical Trials Regulation
• The potential of the new Clinical Trials Information System (CTIS) database
• What challenges the new regulation and database will create
• 10 actions ACT EU suggests to prepare for the future