Out-Law News | 01 Nov 2019 | 9:27 am | 1 min. read
Following a successful pilot exercise, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) announced that it will maintain its first two fast-track procedures for the authorisation of medical product clinical trials.
In some cases under the new scheme, authorisation for the trials could be obtained within 25 days.
The ANSM said it established the scheme to "reduce clinical trial application processing time and accelerate access to innovation for patients waiting on therapeutic solutions".
The fast-track procedure established by the ANSM provides two distinct routes that pharmaceutical companies can follow to obtain speedy authorisation for clinical trials, depending on the nature of the product they wish to trial.
The 'access to innovation' track relates to innovative treatments, such as those in the field of paediatric oncology and haematology and rare diseases in early trial phases.
The 'support for development' track concerns substances or combinations already evaluated in France for the same indication/disease, target population or treatment.
The application processing time for clinical trials under the 'access to innovation' scheme is 40 days for innovative treatments and clinical trials having a complex design, and up to 110 days where the trials would involve medicines classed as 'advanced therapy medicinal products' (ATMPs).
Clinical trials for medicines can be authorised within 25 days via the 'support for development' track, unless the medicines are ATMPs. In those cases, the processing period could last 60 days.
"The guiding principle of these circuits is to promote better file preparation so that files meet quality and patient safety requirements," the French regulator said.
The ANSM said that, as of earlier September 2019, its fast track procedure had seen more than 40 applications for clinical trials filed and processed. A separate evaluation of the procedure for ATMPs is to take place before the end of the year.
The regulator said that the success of the pilot initiative coupled with "its commitment to promote access to innovation for patients while protecting their safety" has spurred it to maintain its fast track programme. It said the move will help prepare the country for the implementation of new EU regulations on clinical trials set to take effect in 2020.
The ANSM had published a practical guide for applicants earlier this year.
The ANSM announced late last year that it will introduce a third fast-track route to support speedier authorisation of clinical trials concerning innovative therapies (gene and cell therapies) aiming at reducing the application processing time from 180 day to 110 days.