France – Clinical trials on medicinal products submitted to the ANSM as part of the FastTrack procedure

Making health innovation accessible faster for patients is a priority that the government has posted in the CSIS 2018 (Strategic Council of Health Industries) and that the ANSM, guarantor of the safety and quality of the authorizations issued, integrated into its 2018 work program.
Two fast-track programmes are planned within the context of the ANSM’s priority projects, focussed on access to innovation and support for development respectively.
This procedure aims to reduce clinical trial authorisation application processing times, to prepare the ANSM to be more responsive in provision of the future European regulations on clinical trials, and to improve the quality and safety of the submitted applications.
The main challenge in setting up this Fast-Track procedure for medicinal product clinical trials is to enable more rapid access to:
– innovative treatments for patients (“Access to innovation” – Fast-Track 1)
– implementation of new clinical trials on known substances (« Support for development” –  FastTrack 2)
A first phase of this test procedure has been proposed to volunteer sponsors as of October 15, 2018.
A second phase aimed at broadening the scope of this procedure, in particular to advanced therapy drugs, will be offered to volunteer sponsors as of February 18, 2019…