After a successful test phase, ANSM has decided to maintain its two accelerated circuits for medicinal product clinical trial authorisations (Fast Track).
These circuits were established on 15 October 2018 as an initial test run and on a voluntary basis to reduce clinical trial authorisation application processing times and accelerate access to innovation for patients waiting on therapeutic solutions, and to prepare for the future European clinical trial regulation’s entry into force in France (scheduled for spring 2020). They concerned initially clinical trials of innovative treatments (‘Access to innovation’ → Fast Track 1) as well as new trials of known substances (‘Support for development’ → Fast Track 2).
From 18 February 2019 the ANSM extended the scope of the Fast Track clinical trials applications to clinical trials with a complex design and Advanced Therapy Medicinal Products (ATMP).
Fast Track 1: Access to innovation
For innovative treatments and clinical trials having a complex design (Fast Track 1), the application processing time is up to 40 days (versus 60 days with current CT regulation) and up to 110 days for clinical trials involving new ATMPs (versus 180 days with current CT regulation).
Fast Track 2: Support for development
For clinical trials involving drugs already known to ANSM (Fast Track 2), the application processing time is up to 25 days for medicinal products (versus 60 days with current CT regulation) and up to 60 days for ATMPs (versus 180 days with current CT regulation).
The Fast Track programme has now been the subject of an evaluation and as of early September 2019, over 40 medicinal product clinical trial authorisations had been filed and processed through this procedure. The procedure for ATMPs will be evaluated in the last quarter of 2019.
=> In light of this success and its commitment to promote access to innovation for patients while protecting their safety, the ANSM has decided to maintain the Fast Track programme.
Additional information pertaining to these accelerated circuits and eligibility conditions are available at:
Please contact us directly for queries on how EUDRAC can assist you with your applications.