Module 5 Presentations

05/07/2024

Transition framework

• Legal basis : Article 98 of Regulation (EU) 536/2014 permits transition of clinical trials ongoing under the Directive 2001/20/EC to the Regulation 536/2014 within 3 years from the date the CTR became applicable. Transition period ends 30 January 2025 (submission deadline 16 October 2024) • Trials in scope: • Clinical trials authorised under the CTD • At least one active site in the EU on 30 January 2025 • Trials that have ended locally in all EU/EEA 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 • Only clinical trials without any ongoing amendment assessment of documents in any of the EU/EEA countries eligible. Procedure completion or withdrawal to be considered. • Transitioning application in CTIS to be processed (decision in place by 30Jan2025) • Risk of corrective measures or other legal sanctions if ongoing trials not transitioned

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

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Transition: Referencesand Guidance

• EudraLex Volume 10 • Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation ( here ) • Clinical Trials Coordination Group (CTCG) of HMA • Best Practice Guide for sponsors of multinational clinical trials with different protocol versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014 ( here ) • Cover letter template ( here ) • Best practice guide naming of documents in CTIS ( here ) • EMA Clinical Trials Information System: training and support • Clinical Trial Information System (CTIS) evaluation timelines ( here )

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

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