This morning the Official Journal of the European Union published the Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation 726/2004.Article 57 provides for the European Medicines Agency to establish the EudraPharm database on medicinal products authorised in the Community to be accessible to the general public. Where appropriate, EudraPharm should also include references to data on clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 11 of Directive 2001/20 — the EudraCT database).
The purpose of this guideline is to identify the data elements from the EudraCT database corresponding to the information to be included in EudraPharm, to identify the trials which will be included and to set out the criteria for the update of this data. The idea is to provide relevant information in the interests of public health. EudraCT data fields are mainly consistent with international initiatives relating to clinical trial registries such as the WHO International Clinical Trials Registry Platform and the International Committee of Medical Journal Editors (ICMJE). Although EudraCT may have additional fields, the convergence of the information to be made public with the WHO ICTRP facilitates the work of sponsors and researchers submitting information to different registries for different purposes, and facilitates the access of patients, health professionals and citizens in general to this information.
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