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France Begins Speeding Clinical Trial Start-Up Times

Posted 12 November 2018 | By Zachary Brennan 

France Begins Speeding Clinical Trial Start-Up Times

As part of a push to more quickly offer patients access to innovative treatments, France’s drug regulator, known as ANSM, has established two “Fast Track” options that will expedite the authorization of clinical trials.

Unlike the US Food and Drug Administration’s (FDA) Fast Track process, which is designed to expedite the review of drugs to treat serious conditions and fill an unmet medical need, France’s new designation concerns clinical trials of innovative treatments as well as new trials of known substances.

The new voluntary “Fast Track” process means trial approval times will be shortened by either 20 days or 35 days, depending on if it’s a new or known substance. For new substances, eligibility criteria include early phase trials, pediatric oncology and pediatric hematology trials or rare disease trials. For known substances, eligibility criteria include that a substance or combination of substances are already evaluated in France and in the same indication as the trial concerned.

Non-eligibility criteria for new substances include trials on healthy volunteers, trials with complex design and trials for advanced therapy medicinal products (ATMPs). Non-eligibility criteria supporting a known substance trial include if it’s the first trial in France, and if there’s a complex design or it’s an ATMP.

“The new system will come into force starting 15 October 2018 and Fast Track processing times will not exceed 25 or 40 days, depending on the type of trial, whereas current regulations call for 60 days,” ANSM said. “This new system aims to shorten clinical trial authorization application processing times, prepare the ANSM for greater responsiveness in view of upcoming European regulations on clinical trials—coming into effect no later than 2020—and improve the quality and safety of the clinical trials proposed in submitted applications.”

The objective is to ensure faster turnaround times for making innovative treatments available to patients.

ANSM says that for questions about clinical trial application submission procedures or to schedule a Fast Track 1 presubmission meeting, email questions.clinicaltrials@ansm.sante.fr. Submission of Fast Track clinical trial applications can be made to: aec-essaiscliniques@ansm.sante.fr.

ANSM

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