On 15 October 2018, in preparation for the application of the EU Clinical Trials Regulation, the National Agency for Medicines and Health Products Safety (ANSM) introduced two fast-track procedures to allow faster patient access to innovations. The Clinical Trials Regulation is expected to become applicable in 2020.
Fast-track procedure 1, “access to innovation”, aims to provide rapid access to advanced therapy products (paediatric oncology/haematology and rare diseases) in phase I and II clinical trials. Fast-track procedure 2, “support of development”, aims to accelerate the implementation of clinical trials for substances or combinations of substances already evaluated by the ANSM and in the same indication, disease, target population or treatment as the trial concerned.
The new procedures will reduce deadlines for the authorisation of clinical trials for new treatments from 60 to 40 days and for authorisation of new trials in known substances from 60 to 25 days, while improving the quality and safety of dossiers.
The ANSM has published guidelines as well as application forms, in English, on its website to provide more detailed guidance to applicants. In particular, the “Practical Information Guide for Applicants” clarifies that the new fast-track procedures are optional, based on a voluntary approach for sponsors and applicable on a trial by trial basis. They can apply to clinical trials involving medicinal products (including radiopharmaceuticals) from any therapeutic area, in any phase (including initial clinical trial authorisations), and that have academic or private clinical trial sponsors.
The fast-track procedures will not apply to clinical trials involving:
- Medicinal products that were previously subject to: (i) a voluntary harmonisation procedure, where France is the referent or concerned national authority and took part in it; (ii) a pilot phase procedure applying the deadlines of the Clinical Trials Regulation; or (iii) a combined trial with another health product.
- Innovative medicinal products (such as gene therapy or cell/tissue engineering products).
- Health products other than medicines (such as medical devices, cosmetics, cell therapy preparations, organs, or tissues and labile blood products).
In addition, the fast-track procedures will not apply to non-interventional trials and research with minor risks or constraints, or any follow-up of clinical trials, including those submitted as part of the fast-track procedures and at the end of the trial.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, October 2018 Issue (Thomson Reuters).