On January 26, 2023, the European Medicines Agency clarified the transition period and the date from which CTIS will become mandatory.
An initial EU/EEA clinical trial application (CTA) must be submitted by January 30, 2023, in accordance with the CT Directive. As of January 31, 2023, clinical trial sponsors must use CTIS to submit an application to start a new clinical study in the EU/EEA.
Trials approved under the CT Directive can continue in EudraCT until the end of the three-year transition period (January 30, 2025) but adding a new EU/EEA member state to the trial will require a new application through CTIS.
Member states’ guide (v1.3), Sponsors’ guide (v1.3), and FAQs (v1.3) were also updated with the above information in Module 23 – Transitional trials of the page Clinical Trials Information System (CTIS): online modular training program.