NEW EU COMMISSION DECISION ON CLINICAL TRIALS

An EU Commission decision on the compliance of the EU portal and the EU database for clinical trials of medicinal products for human use with the requirements referred to in Article 82(2) of Regulation (EU) No 536/2014 of the European Parliament and of the Council (hereinafter: “EU Regulation”) was published in the Official Journal of the European Union on July 31, 2021.

The European Medicines Agency, in collaboration with the Member States and the Commission, set up a portal at Union level as a single-entry point for the submission of data and information relating to clinical trials. For the proper functioning of the EU portal, an EU database was set up at Union level, that will contain the data and information submitted.

After the initial inspections, it was verified that the EU portal and the EU database fulfilled the EU Regulation’s conditions of full functionality and compliance with the functional specifications.

The Decision entered into force on the day of its publication, that is on July 31, 2021.