Sponsors and investigators are advised that the deadline for transitioning clinical trials from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR) is 30 January 2025. Ongoing trials that have not ended by this date must transition to the CTR to continue lawfully. This includes trials with active sites where the Last Patient/Last Visit (LPLV) has not yet occurred and trial-specific activities are ongoing. Multinational trials without active sites in Denmark but with active sites in other Member States must transition in those states only. Mononational trials in Denmark that have notified the Danish Medicines Agency of the end of trial (LPLV) do not need to transition.
Before transitioning, all applications for substantial amendments under the CTD must be completed, taking into account the assessment times of the Danish Medicines Agency and the Medical Research Ethics Committees. For multinational trials, it's essential to ensure that all Part I documents of the application are harmonized or consolidated, meaning the protocol must be identical across all Member States or specify any national differences in a consolidated document. The Investigator's Brochure and the Investigational Medicinal Product Dossier may also need harmonization or consolidation.
The review of transitioning applications has been agreed to be shortened to one week following the receipt of a valid application, with the application needing to be authorized by 30 January 2025. Guidance documents have been provided to facilitate the transition process, including the GCP Units guide, European Commission Eudralex volume 10, CTCG’s best practice guide, EMA’s Module 23, and the CTIS Sponsor Handbook.
After transitioning to the CTR, when submitting the first Substantial Modification (SM), all Part I documents must be updated to comply with CTR requirements. In Denmark, only documents changed as a result of the submitted SM need to be updated for Part II. Sponsors may delay submitting the first SM until there are planned changes to the dossier, but all Part I documents must be updated before applying for the addition of a new member state to the trial.
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