TRANSITION
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. Sponsors are, therefore, requested to transition to the legal framework of the CTR the ongoing clinical trials that are currently under the regime of the Clinical Trials Directive (CTD) and expected to be ongoing after 30 January 2025. This must be done by using the Clinical Trials Information System (CTIS).
Detailes:
EudraLex - Volume 10 - Clinical trials guidelines:
