France to Maintain Fast Track Schemes for Clinical Trials

As the new EU clinical trial regulation is expected to take effect next spring, France’s drug regulator, Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), said it will maintain two fast tracks to speed clinical trials for new and already known medicinal products.

The two fast track processes, which were established last year and then extended to advanced therapy medicinal products (ATMPs) in February, allow for innovative drug trial applications to be processed in up to 40 days (and 110 days for ATMPs) and up to 25 days for already known drugs (and 60 days for already known ATMPs).

The fast tracks mean trial approval times have been shortened by either 20 days for innovative products or 35 days for known substances. ATMP trial applications previously took 180 days to be reviewed and accepted, ANSM said.

The regulator also said early tests of the two tracks have proven successful.

“As of early September 2019, over 40 medicinal product clinical trial authorisations had been filed and processed through the ‘fast-track’ procedure, respecting the Agency's commitment to respond within an accelerated timeframe. The procedure for ATMPs will be evaluated in the last quarter of 2019,” ANSM said.

For more on filing under the fast tracks and submitting specific documents, see the link below.

ANSM