All clinical trials that will not be finished in the EU/EEA until the end of the transition period (30 January 2025) need to transit from the EU Directive 2001/20/EC (CTD) to the EU Regulation 536/2014 (CTR). Until 30 January 2025, the transition must be submitted, validated, assessed, and authorised, otherwise the clinical trial is being conducted without authorisation which is considered non-compliant under current law.