EU Clinical Trials Register
- Letter to stakeholders | 391 KBJoint letter by the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) concerning the obligation to publish results in EudraCT02/07/2019
The European Union Clinical Trials Register provides protocol and result searches for:
- clinical trials on medicinal products that are conducted in the European Union (EU) and the European Economic Area (EEA)
- clinical trials on medicinal products conducted outside the EU / EEA that are linked to European paediatric-medicinal product development
The information contained in the EU Clinical Trials Register is extracted from EudraCT, the EU Clinical Trials database. This information is provided by the sponsor of the clinical trial in electronic form (=application form) as part of the dossier submitted to the National Competent Authority concerned. The authority loads the application form into the EudraCT database and adds information on agency review and the opinion by the ethics committee.
As of 21 July 2014 it became mandatory for sponsors to post clinical trial results in the EudraCT database. This concerns future, ongoing and completed clinical trials.