EudraCT

EudraCT is the European Union Drug Regulatory Authorities Clinical Trials database, a centralized repository of information on all clinical trials involving medicinal products conducted in the European Union (EU) and European Economic Area (EEA). It was established by the European Union to support the Clinical Trials Directive (2001/20/EC) and to streamline authorization, oversight, and reporting for interventional trials across member states. The database is administered by the European Medicines Agency (EMA) on behalf of EU member states.

Data included: trial identification number assigned to each protocol, trial title, sponsor, medicinal product involved, therapeutic area, trial phase, objectives, designs, inclusion/exclusion criteria, endpoints, participating member states, ethics committee approvals, and current status (e.g., ongoing, completed, halted). It serves as a centralized reference for regulators, researchers, and industry, helping harmonize information and monitor safety.

Access and publication: EudraCT records have been accessible to the public to varying degrees; historical trial data and critical information were publicly available, subject to privacy and commercial confidentiality constraints. The system supported regulatory workflow for trial authorization, modifications, and safety reporting in the EU.

Regulatory evolution: With Regulation (EU) 536/2014, the Clinical Trials Information System (CTIS) was established as the centralized platform for trial submissions and management in the EU. When fully implemented, CTIS integrates and replaces aspects of EudraCT for new trials; older EudraCT records remain as a historical archive.