French Launch Fast-Track Clinical Trial Approval Scheme
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.
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Updated guidance on France’s experimental fast-track procedure for approving clinical trials shows that the pathway has entered a new phase.
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.
A French pilot project testing out the future EU clinical trial authorization procedures has borne fruit after the first two years, but the regulator wants many more sponsors to use the pilot so that the country is ready for the new rules in 2019.