Clinical Trials Information System mandatory in 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).

According to the European Medicines Agency (EMA), 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.

Understanding the new EU Clinical Trial Regulation: seven things sponsors should know

Historically, to gain regulatory approval to run a clinical trial, sponsors have needed to submit clinical trial applications separately to national competent authorities (NCAs) and ethics committees in each country. 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.

Clinical Trials Information System

The future of clinical trial applications in the EU 

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. Location and which NCA or national ethics committee sponsors are dealing with will not be taken into consideration.

The CTR foresees a three-year transition period, from 2022 to 2025. In the next two years, by 31 January 2025, all ongoing trials approved under the Clinical Trials Directive will be governed by the new Regulation and will have to be transitioned to CTIS.

Ultimately, the application of the CTR strengthens Europe’s position as an attractive location for clinical research, the EMA asserted. 

Who regulates clinical trials in the EU/EEA?

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