Mastering the Final Countdown | Transitioning to the EU-CTR

With the rise of single shared system Risk Evaluation and Mitigation Strategy (REMS) requirements, pharmaceutical companies must coordinate and reach consensus with their rivals to effectively meet FDA demands.

In the high-stakes pharmaceutical arena, cooperation among manufacturers of competing brands is an unusual concept. With the rise of single shared system Risk Evaluation and Mitigation Strategy (REMS) requirements, however, pharmaceutical companies are faced with the need to coordinate and reach consensus with their rivals in order to effectively meet the FDA's demands.

The clock is ticking for clinical trials operating under the EU Clinical Trial Directive (CTD). As of January 31, 2025, all ongoing trials in the EU/EEA must either be completed or transitioned to the new EU Clinical Trial Regulation (CTR). With the deadline fast approaching, sponsors face a tight window to ensure their trials remain compliant under the new regulatory framework. The transition is far from just a paperwork shuffle—it represents a fundamental shift in how clinical trials are regulated across Europe. [Read the full report here.]?

Why Does This Transition Matter?

The EU-CTR was introduced to streamline the process of conducting clinical trials across multiple EU member states, promoting greater transparency and harmonization of the approval process across EU/EEA. But for trials that were already authorized under the old CTD, the process of transitioning to this new system requires careful planning. Failure to do so could mean non-compliance, leading to delays or even the halting of important research.?

The transition process is more than just a regulatory hurdle; it reflects the changing landscape of clinical trials in Europe, where digitalization and transparency are at the forefront. For sponsors still operating under the old CTD, the final deadline poses both operational challenges and an opportunity to modernize their approach.?

Expedited Transition Window for EU-CTR Closing Soon

One critical aspect of this process is the expedited, harmonized evaluation procedure established by the EU Clinical Trial Coordination Group (CTCG). Open until October 16, 2024, this procedure is designed to simplify the transition for trials by allowing sponsors to submit minimal application documents that were already authorized under the CTD. After this window closes, the process could become more cumbersome, adding to the urgency for sponsors to act swiftly.?

What Operational Challenges Lie Ahead??

The operational challenges of this transition are not trivial. Sponsors must ensure that any ongoing trial involving at least one active site in the EU beyond January 30, 2025, is fully transitioned. This means navigating a maze of regulatory requirements, including the need to submit transition applications through the Clinical Trial Information System (CTIS), update essential trial documents, and ensure compliance with the CTR's enhanced transparency rules.?

Sponsors must also coordinate with the relevant member states to ensure that regulatory authority and ethics committee assessments are completed before submitting the transition application. Trials that have temporarily halted for safety reasons must also be carefully managed, with sponsors required to notify authorities of their plans to resume after the transition.?

Strategic Considerations for EU-CTR Success?

For sponsors, the key to a smooth transition lies in preparation. Understanding the basic principles of the CTR transition process is essential, and sponsors are required to have a harmonized or consolidated version of relevant trial documents—such as the protocol, investigator's brochure, and investigational medicinal product dossier—before submitting their applications. Harmonizing these documents across all EU member states will avoid complications during the approval process.?

Additionally, sponsors must ensure that all the necessary organizational steps are completed. This includes registering in the European Medicines Agency’s Organization Management System (OMS) and creating an account in the CTIS portal. Having the appropriate administrative roles assigned within the organization is also crucial to ensure that the application process runs smoothly.?

The Countdown to EU-CTR Compliance?

With the deadline for the EU-CTR transition just around the corner, time is of the essence for sponsors who have yet to take action. The transition is not just an administrative exercise; it’s an opportunity to align with a more modern, transparent, and harmonized clinical trial framework that promises to make the EU a more attractive region for clinical research.?

Sponsors should take this final stretch seriously—preparation, attention to detail, and swift action are the only ways to ensure their trials remain CTR compliant and on track.?

Is your team looking to optimize their EU-CTR transition strategy? Talk with our regulatory experts.?

Contributors?

Shivam Vashisth | Principal Regulatory Affairs Consultant?

[email protected]?

Marion Ebon Sch?ffel | Associate Director, Regulatory Consulting?

[email protected]?

Fabienne Lekaim | Director, Regulatory Consulting?

[email protected]??

Fatima Pimentel |?Director, Regulatory Consulting?

[email protected]??

Reda Boumezber | Senior Regulatory Consultant?

[email protected]??

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