EU Clinical Trials Regulation: Time Is Running Out, Are You Ready?

On January 31, 2022, the EU Clinical Trials Regulation 536/2014 (CTR) came into force with a transition period of three years. Now, as that transition period comes to a close, the process and need for registering new clinical trials is old news to sponsors, however there's one more step needed to ensure compliance. Clinical trials registered under the previous EU Clinical Trials Directive (EU-CTD), that are expected to continue after January 30, 2025, are now called Transitional Trials, and these are also required to be transitioned to EU-CTR by the deadline. Please note, this does not apply to non-interventional clinical trials of medicines (observational studies on authorized medicines). For those ongoing interventional studies though, time is running out, are you ready?

Here are some areas to review in your clinical trial program to help assess your preparedness.

Clinical Trials Information System (CTIS)

For any ongoing clinical trials after 31 January 2025, sponsors will have access to the CTIS, which supports the business processes of clinical trial sponsors and national regulators throughout the lifecycle of a clinical trial, using secure workspaces. However, sponsors often delegate access to the CTIS to their CROs. CTIS is the framework through which information flows between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) countries, and the European Commission. If you're not using this system, you may be missing critical insights that could enhance your efficiency and safety in the development of new drugs, therapies, and medical devices.

Periodic and Expedited Submissions

If periodic and expedited submissions for a clinical trial still involve multiple safety submissions to NCAs and ECs within the EU, chances are you are still working under EU-CTD. EU-CTR requires all safety reporting to be performed through EudraVigilance, with one submission for all relevant parties. With this new CTIS, the difference in submission time and costs is substantial, so transitioning to EU-CTR will make a significant difference, especially on global trials.

Next Steps for EU-CTR

As of January 31, 2025, all clinical trials still running under EU-CTD must cease until they are transitioned over to meet EU-CTR requirements. So, what is required to keep those clinical trials active? In order to transition a trial from EudraCT to CTIS, a Clinical Trial Application (CTA) marked as a Transitional Trial must be submitted. When preparing a draft Transitional Trial Application, sponsors must provide all mandatory data and documents required in CTIS, even if those were not a requirement under the CT Directive.

It's critical for sponsors within the CTIS to manage the roles and permissions assigned. With the Transitional Trials process, only certain roles may view, update, or submit an application. The CT Admin and Application Submitter are the only two roles that can create and submit a Transitional Trial within CTIS so care must be taken when assigning these roles.

Once the application is complete and submitted, there is of course a waiting period for approval. The Transition of clinical trials from the CTD to the CTR sets an expedited timeline for the transition procedure of minimum dossiers for multinational trials restricted to documents already approved under the CTD estimated to be a maximum of 22 days. Therefore, sponsors are advised to submit their Transitional Trials to CTIS early enough before the end of the transition period to avoid any problems.

Our EU-CTR Experts Are Here to Help

Transitioning from the Clinical Trial Directive to the Clinical Trial Regulation may seem daunting, but with proper planning, preparation, and collaboration, you can navigate this change successfully. Embrace the opportunities presented by the CTR to streamline your trial processes, prioritize patient safety, and contribute to more robust and transparent clinical research in the European Union. Ultimately, this transition is a pivotal step toward advancing medical research and improving patient care in the EU.

Reach out to the ProPharma team to discuss transition planning today—the benefits are clear, and time is running out.

Blog Author

Laura Hopper

President, Pharmacovigilance