Clinical trials in the European Union

This website supports the undertaking and oversight of clinical trials in the European Union (EU) and European Economic Area (EEA).

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.

A clinical trial is a study performed to investigate the safety or efficacy of a medicine. For human medicines, these studies are carried out in human volunteers.

illustration to show the connection between running clinical trials and the importance to patients

CTIS for sponsors

Clinical trial sponsors and other organisations involved in running clinical trials can apply to run a trial and can manage an ongoing trial in up to 30 countries in the European Union and European Economic Area via the Clinical Trials Information System (CTIS).

CTIS for authorities

Regulatory authorities, such as national competent authorities and ethics committees of EU Member States and European Economic Area countries can participate in the assessment, authorisation or oversight of a trial.

Searching for clinical trials

This website initially provides limited information on individual clinical trials in the European Union and European Economic Area. It will gradually contain more information as clinical trial sponsors and regulators use it to initiate and oversee clinical trials since the launch of this website and the database underpinning this website, on 31 January 2022.

Clinical trials with a decision issued after mid-August 2022 that have deferrals of any type in the application form are currently not published on CTIS. This is a temporary measure until the functionalities of the public portal are fully restored.

 

Information on individual clinical trials initiated in the European Union and the European Economic Area before 31 January 2022 can be found in the European Union Clinical Trials Register.

Transition period

By 31 January 2025, any ongoing trials approved under the Clinical Trials Directive will fall under the Clinical Trials Regulation.

EMA news and events

Find EMA news and events related to clinical trials in the EU and the EEA.