Since January 2022, the new Clinical Trial Regulation (CTR) has been in force, which replaced the Clinical Trial Directive (CTD). With the CTR, also a new online portal for clinical trials, the Clinical Trial Information System (CTIS) is introduced. Sponsors and regulators use this single-entry point for clinical trial data for all submissions and assessments. Currently, we are in the middle of a transition period from the previous EudraCT system to CTIS. Since January 2023, all new clinical trial applications already have to be submitted via CTIS.
For clinical trials approved under the CTD, that will still be ongoing with at least one active site within the EU/EEA after the 30th of January 2025, it is mandatory to be transitioned to CTIS. To prevent the risk that a study must be terminated due to not being transitioned in time, the transition process should be started on time. Thereby taking into account a standard review timeline of 60 days, which may be prolonged by possible requests for information (RFIs) and/or the two-week winter clock stop. Furthermore, a transitional CTA cannot be submitted when there are ongoing assessments (e.g., substantial amendments). Therefore, good planning is key! We offer support in transitioning your clinical trial(s) to CTIS, in case help is required.