Clinical Trials Regulation - Version 6.5 of the Q&As

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

The European Commission (EC) published an updated Version 6.5 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). The Q&As entered into force together with the application of the CTR on 31 January 2022.

New Guidance for the Transition of Clinical Trials from the CTD to the CTR

Compared to the previous Version 6.4 Chapter 11 of the Q&As on transitional trials has been deleted and a new guidance document has been developed.

Amongst others, it has now been clarified which Clinical Trials (CTs) have to be transitioned from the CTD to the CTR. Only CTs authorized under the Clinical Trials Directive (CTD) with at least one active site in the EU on 30 January 2025 need to be transitioned. Active site in the context of transitional trials means that the last visit of the last subject (or other trial-specific interventions with the subject specified in the protocol) will take place after 30 January 2025. This means that CTs with no active sites do not need to be transitioned. Trials that have ended locally in all EU/EEA Member States (MSs), in line with the CTD, will not need to be transitioned, even in the case where the global end of trial has not been reached yet.

However, it is still emphasized that for CTD studies that do not convert to CTR, the obligation to submit results reports in EudraCT will remain in place and EudraCT will accordingly remain open for the submission of CT result summaries after 30 January 2025. This also applies to pediatric studies outside the EU until further notice. Also, an application for transfer of a CTD study only needs to be submitted to the affected MSs where the study will be conducted and where there will still be active sites on 30 January 2025. The guidance also explains in question 6 the important aspect of the necessary harmonization of the protocol in multinational trials before transfer to the CTR and how this can be achieved.

More information is available in the CLINICAL TRIALS REGULATION (EU) NO 536/2014 - QUESTIONS & ANSWERS VERSION 6.5 and in the new Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation available in EudraLex - Volume 10 - Clinical trials guidelines.