January 2023: Use of CTIS Becomes Mandatory for New Clinical Trial Applications in the EU

On January 31, 2023, European Medicines Agency updated about the completion of the first milestone of Clinical Trials Regulation.

All initial clinical trial applications in the European Union (EU) must be submitted through the Clinical Trials Information System starting on January 31, 2023.

A three-year transition phase, from 2022 to 2025, is foreseen by the CTR. By the end of the next two years, on January 31, 2025, all current studies that were authorized under the Clinical Trials Directive will be subject to the new Regulation and will need to be transitioned to CTIS. The first milestone has been reached today.

All clinical trial sponsors will now use the same system and follow the same procedures to apply for the authorization of a clinical trial, regardless of where they are located or which National Competent Authority (NCA) or national ethics committee they are dealing with. The new regulation streamlines the processes for the application and supervision of clinical trials, as well as their public registration.