On 19 July 2023, the European Commission published a guidance document concerning the steps to be taken in the transition of clinical trials from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR). Ongoing clinical trials must fully transition to the CTR by 31 January 2025. It is acknowledged, however, that this process involves lengthy timelines and administrative burdens. The guidance document reflects agreement by the representatives of the European Union Member States within the Clinical Trials Advisory Group in relation to these challenges. The harmonized position of the EU Member States presented in the guidance document supersedes Chapter 11 of the European Commission’s Q&A document on the CTR.

The guidance provides that:

  • Transition to the CTR is an administrative process following which assessment by EU Member States will be reduced to the minimum required to ensure compliance.
  • Sponsors are encouraged to register clinical trials under the new Clinical Trials Information System (CTIS) at their earliest convenience to avoid delays.
  • Documentation that was previously assessed will not be reassessed. This means that additional part I and II documents in Annex I to the CTR which were already approved under the CTD will not be reassessed.
  • Templates that were developed and endorsed by the EU Clinical Trials Expert Group as part of EudraLex Volume 10 to provide compliance with the CTR do not need to be updated.
  • There is no need to retrospectively create a site suitability form. These forms are only necessary for new trial sites added through substantial modification to part II documents after initial trial approval.

Transition to the CTR includes an obligation to submit a transition application to the CTIS. The guidance document includes direction concerning transition to the CTR and the CTIS regarding:

  • When clinical trials must be transitioned from the directive to the regulation.
  • Conditions for transition of single and multinational trials.
  • Obligations which trial sponsors must fulfil.
  • Consequences of the transition for clinical trial-related obligations under the CTR, such as obligations for notification through the CTIS, safety reporting rules and archiving requirements.
  • The permitted uses of data generated during a clinical trial authorized on the basis of the CTD.
  • Other issues, including steps related to updating trial documents and labels, the addition to the trial of sites in new EU Member States, urgent substantial modifications to a clinical trial and transparency requirements.

Posted by Cooley