EU CTR – end of three-year transition period

As of 31 January 2025, all ongoing clinical trials in the EU are governed by the European Union (EU) Clinical Trials Regulation, or CTR, and managed through the Clinical Trials Information System or CTIS. 

The CTR was passed in 2014 but did not enter into force until 31 January 2022 when CTIS went live. The CTR repealed the Clinical Trials Directive and made major changes to how Clinical Trial Authorisation Applications (CTAAs) are submitted, reviewed, and maintained in the EU. 

The implementation of the CTR allowed for a one-year transition period for new applications for clinical trials (i.e. a sponsor could choose to apply under the Clinical Trials Directive or under the CTR), and a further two years for trials already authorised under the Clinical Trials Directive to either transition to CTR, or to be completed in the EU. 

Underpinning the operation of the CTR is CTIS, an online portal which consists of a sponsor workspace, an authority workspace, and a public website. For any CTAA in the EU, sponsors now make a single electronic application through CTIS, which covers a harmonised scientific/regulatory review together with a national ethical review, and all communications, notifications, and modifications thereafter are managed through this system. 

Under the CTR, Sponsors can submit to one or several member states (MS), or add other MS post-approval. There is also the option to submit a staggered application, where the core scientific (Part I) documents are submitted to all MS, but national ethics (Part II) documents are submitted to some MS initially, and the remainder at a later date. Where a sponsor applies to multiple MS, one MS is nominated to lead the Part I review, and each MS assesses their own Part II. 

Gaining access to and using CTIS can pose a challenge for sponsors new to clinical trials in the EU, or new to the CTR, especially when ensuring adequate sponsor oversight for delegated activities. CTIS itself is periodically updated, and certain elements of CTR are not yet fully implemented within CTIS. If you have questions or face challenges with your clinical trial applications, tranScrip regulatory and clinical experts are at the ready to guide and advise you; we are ready to expedite your development programs and bring effective medicines to patients across the EU and beyond.