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French ANSM decides to maintain fast-track procedures for clinical trials

After a successful test phase, the National Agency for Medicines and Health Products Safety (ANSM) announced in a press release dated 18 October 2019 that it would be maintaining the accelerated circuits for medicinal product clinical trial authorisations. The fast tracks were established on 15 October 2018 and then extended to Advanced Therapy Medicinal Products (ATMPs) and clinical trials having a complex design on 18 February 2019, with the aim of faster patient access to innovations (see our previous blog post: French regulator (ANSM) introduces third fast-track authorisation procedure for clinical trials).

The new procedures reduced deadlines for the authorisation of clinical trials:

  • For innovative treatments, and clinical trials having a complex design, from 60 to 40 days.
  • Involving new ATMPs, up to ten days.
  • Of known substances, from 60 to 25 days.

The fast track procedures make it possible to prepare the future European clinical trial regulation's entry into force in France, scheduled for spring 2020.

As of early September 2019, more than 40 clinical trial authorisations had been filed and processed through the fast-track procedures, in accordance with the ANSM's commitment to respond within an accelerated timeframe. The procedure for ATMPs will be evaluated in the last quarter of 2019.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, December 2019 Issue (Thomson Reuters).

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