EU-Register

EU-Register for Clinical Trials of Medicinal Products

On March, 22nd 2011, the European Medicines Agency (EMA) launched the EU Clinical Trials Register. The online register provides, for the first time, public access to information on interventional clinical trials for medicines authorised in the 27 EU Member States and Iceland, Liechtenstein and Norway.

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 the agency review and the opinion by the ethics committee.

The search functions and information on trials are in English. The EudraCT Database exists since 2004; possibly older data are currently incomplete or out-of-date. The register will be updated gradually; it could therefore take a few months until all authorised clinical trials with medicinal products planned for publication are included. Further information about the caveats and limitations can be found on the register homepage.
 
Throughout the project the Agency worked together with stakeholders, including patients and healthcare professionals, to ensure that their needs were taken into account, to the extent possible at this stage, when designing the register.