The European Medicines Agency (EMA) welcomes the publication of the Clinical Trials Regulation in the Official Journal of the European Union (EU). This legislation will open up a new era for the conduct of clinical trials in the EU, ensuring that Europe remains an attractive centre for clinical research. This will foster European competitiveness and innovative capacity, and facilitate swifter development of new medicines for patients. In addition to simplifying clinical trial approvals, the Regulation foresees transparency on the conduct of trials in the European Economic Area, from the point of their authorisation to the publication of the results of those clinical trials.
Whilst authorisation and oversight of clinical trials remains the competence of Member States, the new legislation mandates the Agency to prepare the IT platforms to support sponsors and experts in the Member States in carrying out their roles in relation to the authorisation of trials, their supervision, safety reporting and compliance activities, as well as to enable public access to information on clinical trials. Read More