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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.
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).
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.
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.
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.
Until 31 January 2023, clinical trial sponsors can choose whether to apply to start a clinical trial via the Clinical Trials Information System (CTIS), the system underpinning this website, or under the Clinical Trials Directive.
Find EMA news and events related to clinical trials in the EU and the EEA.
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