In accordance with the European Regulation on Clinical Trials (Regulation (EU) No 536/2014), applications for clinical trials in the European Economic Area (EEA) could have been submitted centrally via the European Clinical Trials Information System (CTIS) since 31 January 2022. This was also the case for clinical trials that were to be carried out in Germany only and for applications from both academic and commercial sponsors of the clinical trial. After a one-year transitional period, during which sponsors were still free to decide whether to submit an application for a clinical trial via a national procedure or via CTIS, applications for approval of a clinical trial for all newly planned clinical trials in the EEA must be submitted via CTIS beginning on 31 January 2023.
The clinical trials already approved under the old Clinical Trials Directive (2001/20/EC) must also have been transferred by the sponsor to the new CTIS by the end of the next two-year transitional period on 31 January 2025.
CTIS acts as a central interface for clinical trial sponsors applying for approval of a clinical trial and for the medicines authorities and ethics committees evaluating those applications. All applications for approval of a clinical trial in the EEA will thus be submitted and processed via CTIS in a standardised manner as of 31 January 2023. CTIS also offers the possibility to submit applications in several EU or EEA Member States at the same time.
The European Medicines Agency (EMA) set up CTIS and operates the system.
The national medicines authorities of the EU and EEA countries assess and monitor clinical trials in their country using CTIS.
The European Commission ensures the correct interpretation and implementation of the Clinical Trials Regulation.
CTIS includes
Sponsors of clinical trials can prepare their applications for approval of the clinical trials and compile them with all the necessary documents in their secure access area. They will then be able to apply simultaneously for approval using the same documents in all (up to 30) EEA countries.
An automatic publication of application information is integrated into the CTIS system in compliance with the "deferral rules".
The secure area for Member States serves to support activities in the EU/EEA countries and the European Commission regarding the evaluation, approval, and monitoring of clinical trials.
Through the public website (https://euclinicaltrials.eu/), the public can access detailed information on the clinical trials conducted in the EEA once the studies have been approved in CTIS, provided that the conditions for publication have been met. CTIS contains a clinical trial database freely available to the public in order to provide access to clinical trial information.
Updated: 20.01.2023
