SANTE - DG Health and Food Safety
The mission of the Commission Expert Group on Clinical Trials is to provide the Commission with advice and expertise on clinical trials in relation to the preparation and implementation of legislation and policy initiatives. It also assists the Commission to draw up and discuss guidelines and documents related to the transition from the 'Clinical Trials Directive' 2001/20/EC to the ‘Clinical Trial regulation’ EU No 536/2014 and to the implementation of the Regulation. All finalised guidelines and documents are published on the web. To serve as Member States forum to discuss regulatory issues on clinical trials in the EU and for coordination and cooperation with Member States and stakeholders.
Assist the Commission in the preparation of delegated acts
Assists the Commission in drawing up implementing Commission guidelines provided for in the EU legislation on clinical trials.