France Invites Advanced Therapy Makers To Use Fast-Track Trial Approval Pathway

Updated guidance on France’s experimental fast-track procedure for approving clinical trials shows that the pathway has entered a new phase.

Train — French regulators are speeding up approvals for advanced therapy trials. • Source: Shutterstocks

The French regulatory agency, ANSM, has now opened up its experimental fast-track pathway for approving clinical trials to sponsors developing advanced therapy medicinal products (ATMPs), according to an updated guide on how to use the rapid authorization process.

The voluntary pathway, which ANSM began testing last year for other types of medicinal products, may be used by ATMP...