France: To create clinical trial fast track for cell and gene therapies

17-12-2018

France: To create clinical trial fast track for cell and gene therapies

(Source: RAPS 2018-12-17)

France is set to create a fast track for applications to run clinical trials of cell and gene therapies. The proposed regulatory mechanism will cut the time it takes sponsors to receive authorization to start clinical trials to 110 days.

As it stands, France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) can take up to 180 days to assess applications to run clinical trials of cell therapies. The limit for gene therapies is 120 days. If ANSM does not respond within the statutory timeframe, it implies it has not accepted the application. Other regulators treat the lack of a response as a green light to start a trial.

These policies mean filings for clinical trials of cell and gene therapies take longer than those of other modalities. France has a 60-day deadline for authorizing or rejecting applications to run other types of clinical trials, and offers fast tracks that cut the time to as little as 25 days. Following the creation of the fast tracks, ANSM is typically processing clinical trial applications in 45 days.

Having piloted the fast track idea with other types of drug, ANSM now wants to expand its use to the processing of applications to run clinical trials of cell and gene therapies. The fast track, which ANSM plans to create early next year, will set the deadline for decisions at 110 days.

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