European Directive 2001/20/EC on Clinical trials

The European Directive 2001/20/EC on Clinical trials was implemented in 2004 by the Member States and is now being modified into a regulation under development with input from the EORTC along with other stakeholders. Since the first discussions around the directive in the late 1990’s, the EORTC has been interacting with both European and national authorities to address specific issues related to the implementation of the Directive in the context of non-commercial research. As academic sponsor of international clinical trials, the EORTC has been successful in positioning itself as a unique and internationally recognized clinical research organization whose opinion is highly valued, and, in close collaboration of DG Health and Consumers and DG Research and Innovation, is now at the forefront of the multi-stakeholder discussions for improving the regulatory and legal environment but also the funding perspectives for independent clinical research in Europe. EORTC jointly or co-organized several meetings and workshops set-up by the European commission, regulatory authorities, the Federation of European Academies of Medicine (FEAM), the European Forum for Good Clinical Practice (EFGCP), the European Science Foundation (ESF) and other organizations. As a result, a proposal for a new regulation has been submitted by DG SANCO to the European Parliament.

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