From 31 January 2025 onwards only the Clinical Trials Regulation (EU) 536/2014 (CTR) and its Delegated Acts will apply, as laid down in Article 98 thereof. Ongoing clinical trials currently governed by the Clinical Trials Directive (CTD) and expected to continue after 30 January 2025 will need to transition to the CTR regulatory framework. If such clinical trials have not transitioned to the CTR by that date, they will be considered non-compliant and in breach of the CTR. Consequently, sponsors could be subject to corrective measures and penalties by Member States in accordance with Articles 77 and 94, and subject to civil and criminal liability as per Article 95 of the CTR. To ensure the lawful conduct of the clinical trial and thus the safety of the participants and the quality of the trial data, it is the responsibility of the sponsor to complete a transitioning application using the Clinical Trials Information System (CTIS) before 31 January 2025.Only clinical trials authorised under the CTD with at least one active site in the EU foreseen on 30 January 2025 need to transit. ‘Active site’ in the context of the decision to transition a trial 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 Jan 2025.For multinational clinical trials, prior transition: • all documents common to all MSCs which are covered by the Part I assessment report e.g. protocol, Investigator’s Brochure, Investigational Medicinal Product Dossier) will have to be either consolidated or harmonised, as explained in the CTCG best practice for sponsors on transition; • such harmonisation is performed by a request for substantial amendment under the CTD before submitting a transitioning application. That request shall specify the intention of the sponsor to transition that clinical trial to the CTR. It is necessary to obtain the approval of this amendment before submitting the application for transition.
Please contact RegPharmaClin S.L. for transition or harmonisation of documents from your Clinical Trial.
https://www.ema.europa.eu/en/news/clinical-trials-regulation-becomes-fully-applicable