The EU Clinical Trials Register was launched on 22 March 2011 by the European Medicines Agency (EMA). The online register gives for the first time public access to information on clinical trials for medicines authorized in the 27 EU Member States, Iceland, Liechtenstein and Norway. The register contains clinical trials from the industry and those from research organisms and aims to improve the transparency of clinical research in Europe. Information is published once the clinical trial is authorized.
The register is part of EudraPharm, the Community database of authorised medicinal products.
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 and is part of the authorization request to conduct a trial. The information is loaded into the EudraCT database by the national medicines regulatory authority. The authority adds to this information the authorisation of the clinical trial and the assessment by the relevant ethics committee.
The database also allows the public to search for information on clinical trials authorised to be carried out outside the EU if these trials are part of a Paediatric Investigation Plan (PIP). Clinical trials listed on a PIP are research and development programs to collect data needed to support the use of a medicinal product in children.
In this case the information is provided by the PIP addressee directly, via the EMA, to the system.
The approval of clinical trials applications in the European Union is the responsibility of the member states.
Source: EMA press release.