Following the introduction of two fast-track procedures to allow faster patient access to innovations in preparation for the application of the EU Clinical Trials Regulation, the National Agency for Medicines and Health Products Safety (ANSM) implemented another fast-track authorisation procedure (see our previous update, ANSM introduces fast-track authorisation procedures for clinical trials).
On 5 December 2018, the ANSM decided to introduce a new fast-track procedure for innovative medicinal products (such as gene and cell therapies), which as per the ANSM “are regulated by a specific regulatory regime because of their innovative nature”, while the clinical trials involving these medicines had been previously excluded from the scope of the fast-track procedures as indicated in the “Practical Information Guide for Applicants“.
Contrary to the fast-track procedures “access to innovation” and “support of development” which are currently trialling, this third procedure for innovative therapy medicines will be set up in early 2019.
The ANSM aims at reducing the deadlines for the authorisation of clinical trials from 180 days to a maximum 110 days.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, December 2018 Issue (Thomson Reuters).