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.
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A French pilot intended to speed up the authorization of clinical trials is to be continued after a pilot phase showed it was working well.
Experimental gene and cell therapy products are to get a boost from the French regulator in the form of a new fast-track clinical trial approval process. This is the third accelerated pathway to be introduced as part of efforts to speed up patient access to new medicines.
Sponsors are being invited to trial a new fast-track system for authorizing clinical trials as part of French preparations for the new EU trial rules that are set to come into force in 2020.