France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) are to create a fast track for applications to run clinical trials of cell and gene therapies. The proposed regulatory process will reduce the time it takes sponsors to receive authorisation to start clinical trials to 110 days.
Currently, it can take ANSM up to 180 days to assess applications to run clinical trials of cell therapies, and up to 120 days for gene therapies. If ANSM fail to respond within these timeframes, then this implies that they have not accepted the application, however other regulators may treat a no response as a green light to initiate a trial.
For authorising or rejecting applications to start other types of clinical trials, ANSM has a 60-day deadline, and can offer fast tracks which reduce the time to 25 days. Following the introduction of the fast tracks, on average ANSM processes clinical trial applications in 45 days. Therefore, ANSM plan to expand the use of the fast track for processing applications to run clinical trials for cell and gene therapies.
To read more about the ANSM’s clinical trial fast track for cell and gene therapies, please click here.