A new step toward the full implementation of the Clinical Trials Regulation (CTR) just occurred: on 31 January 2023 the Clinical Trial Information System (CTIS) became the mandatory entry point for all activities linked to the submission and assessment of clinical trials. The system can be access at the link https://euclinicaltrials.eu Since that date, is thus not possible anymore for sponsors to submit an initial clinical trial application according to the previous Clinical Trials Directive. The CTIS is characterised by different dedicated workspaces for sponsors, regulators and patients. The sponsors’ workspace supports application for authorisation of a clinical trial in up to 30 European Economic Area (EEA) countries. Sponsors can also use the system to interact with national regulators during the trial and for recording its results.

The workspace for regulators allows national competent authorities and ethics committees to collaborate to run all needed activities along the entire life cycle of a clinical trial, including assessment, authorisation or oversight. The public section includes the searchable database of individual clinical trials granted or refused permission in the EU and EEA since the launch of the CTIS, on 31 January 2022. The information contained in the database is still limited, and it will gradually grow as sponsors and EU/EEA regulators will use the system to initiate and oversee clinical trials in the EU/EEA. The European Union Clinical Trials Register still remains the source of information on individual clinical trials initiated before 31 January 2022.