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Reviews on Recent Clinical Trials


ISSN (Print): 1574-8871
ISSN (Online): 1876-1038


Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation

Author(s): Stéphane Vignot*, Gaelle Guyader, Valérie Salomon, Philippe Vella, Isabelle Yoldjian, Patrick Maison and Christelle Ratignier-Carbonneil

Volume 18, Issue 3, 2023

Published on: 31 July, 2023

Page: [167 - 171] Pages: 5

DOI: 10.2174/1574887118666230320124012

open access plus


The implementation of the new European Clinical Trial Regulation on 31 January 2022, is a major step to promote clinical research in Europe. The French National Agency for Medicines and Health Products Safety (ANSM) proposes to share some key aspects of the preparation for the application of the Regulation initiated in 2017 and to discuss shared indicators that should be considered to monitor clinical trials opportunities on a territory with regards to access to innovation for patients and attractiveness for sponsors. New criteria based on the time from the first request for authorisation to the first inclusion could be of particular interest to appraise the implementation of the European Clinical Trial Regulation.

Keywords: Clinical trials, regulatory science, access to innovation, European regulation, authorisation, indicators.

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