New European Regulation on Clinical Trials, rules and implementation, where are we?

November 20, 2018


Clinical Trials (CT) are currently regulated under the Directive 2001/20/EC. The Directive had a positive impact on the safety, ethic and reliability of data from CT. However, limitations were soon evidenced such as a decreased number of CT in Europe, increased costs and length of the procedure. Therefore, the European Commission decided to replace the Directive by a new Regulation, the “ Regulation EU No 536/2014”, with the aim of restoring the competitiveness in Europe by simplifying and harmonising the requirements.


In this White paper we discuss the main differences between the CT Directive and the CT Regulation and its implementation steps. We also investigate how Member States are implementing the Regulation : either by pilot phases and/or transposition into national laws. And finally, how can we, as Sponsor, get ready for this Regulation ?

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