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Implementation of the Clinical Trials Regulation in the EU and EEA

The Clinical Trials Information System will become mandatory for all authorisation application for a clinical trial in the EU on 31 January 2023
13 Jan 2023
Bioethics, legal and economic issues

On 31 January 2023, the Clinical Trials Information System (CTIS) will become the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data which includes a public searchable database for healthcare professionals, patients, and the public.

The system was launched on 31 January 2022, starting the clock for the one-year transition time for all sponsors of clinical trials. During the transition period clinical trial sponsors can still choose whether to submit an initial clinical trial application in line with the Clinical Trials Directive or under the Clinical Trials Regulation, via CTIS. On 31 January 2023, the use of CTIS will become mandatory.

CTIS is the information system supporting the implementation of the Clinical Trials Regulation, which changes the way that applications for authorisation of clinical trials in the EU are submitted, how the clinical trials are authorised and supervised. The provisions of the Clinical Trial Regulation bring extensive changes in practices by all stakeholders and require effective change management.

Some users have experienced problems with the system. The European Medicines Agency (EMA) is working closely with Member States, the European Commission, and stakeholders to improve the CTIS user experience for core CTIS processes by the time the use of the system becomes mandatory for all new applications. The Agency has invested additional resources to achieve this goal.

EMA is working closely with national competent authorities in the Member State and the European Commission to facilitate the change to the new system for sponsors and other stakeholders. Training material is available to help sponsors submit information on their clinical trials data, including their applications for authorisation of a clinical trial; the material is updated regularly to reflect information needs. EMA is running regular training webinars with sponsors to explain the system and listen to and address concerns.

Clinical trials in the EU and EEA are governed by the Clinical Trials Regulation (Regulation (EU) No 536/2014) which came into application on 31 January 2022. It is part of a broad initiative to transform the EU/EEA clinical trials environment in support of large clinical trials in multiple European countries, to the benefit of medical innovation and patients. The regulation of clinical trials aims to ensure that the rights, safety, and well-being of clinical trial participants are protected, and the results of clinical trials are reliable and informative.

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