Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU

From 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). CTIS is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data. This follows a one-year transition, during which sponsors could choose whether to apply for a new clinical trial in the EU/EEA in line with the Clinical Trials Directive or under the new Clinical Trials Regulation (CTR), which entered into application on 31 January 2022.

In the past, sponsors had to submit clinical trial applications separately to national competent authorities (NCAs) and ethics committees in each country to gain regulatory approval to run a clinical trial. Registration and the posting of results were also separate processes. With CTIS, sponsors can now apply for authorisations in up to 30 EU/EEA countries at the same time and with the same documentation. The system includes a public, searchable database for healthcare professionals, patients, and other interested parties.

The CTR foresees a three-year transition period, from 2022 to 2025. The first milestone has been reached today; in the next two years, by 31 January 2025, all ongoing trials that were approved under the Clinical Trials Directive will be governed by the new Regulation and will have to be transitioned to CTIS.

The application of the CTR strengthens Europe as an attractive location for clinical research. The new regulation streamlines the processes for the application and supervision of clinical trials, and their public registration: all clinical trial sponsors will now use the same system and follow the same procedures to apply for the authorisation of a clinical trial, no matter where they are located and which National Competent Authority (NCA) or national ethics committee they are dealing with.

The authorisation and oversight of clinical trials is the responsibility of EU/EEA Member States while the European Medicines Agency (EMA) is responsible for maintaining CTIS. The European Commission (EC) oversees the implementation of the Clinical Trials Regulation.