Clinical Trials Regulation (EU) No 536/2014: Questions & Answers

On 24 February 2021 the European Commission released the draft Q&A on EU clinical trials regulation No 536/2014, version 3.

This document aims at informing on the technical aspects of Commission Clinical Trials Regulation (EU) No 356/2014 with a view to facilitating its implementation.

This document sets out frequently-asked 'questions and answers' regarding the implementation of the rules on clinical trials. All updates to this questions and answers document are presented and discussed within the “Expert group on clinical trials” and reflects the view of the group. This group is chaired by the Commission and is composed of representatives of all EU Member States and EEA contracting parties.

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