11 May 2020 - Authored by:Eveline Van Keymeulen
On 21 April 2020, the French National Agency for Medicines and Health Products Safety (ANSM) stated in a publication that since the beginning of the Covid-19 coronavirus pandemic, the ANSM, Directorate-General of Health (DGS) and Protection of Persons Committees (CPPs (also known as ethics committees)) have put in place accelerated procedures to evaluate requests for authorisations for clinical trials involving the management of patients with Covid-19.
In order to respond to the urgency of the pandemic, the ANSM has assessed requests within an average of seven days, compared to 60 days under regulatory timelines. As at 10 April 2020, the ANSM had received 52 applications for clinical trial authorisations and more than two thirds of the projects were authorised. Of the submissions, 19 concern hydroxychloroquine and choloroquine (13 being already authorised). The list of COVID-19 research projects involving humans (which includes both therapeutic and non-therapeutic studies) is available on the Health Ministry website. The list includes projects that have been authorised as well as those still being assessed.
The ANSM also indicated that some of these clinical trials will be not only be conducted in France but will involve other European countries. France is involved in seven out of ten major international trials that are currently underway and is actively participating in European clinical research and being transparent with its data.
While acknowledging the procedural incentive of accelerated assessment, the ANSM insisted on the fact that patient safety remains the main priority and that each clinical trial is monitored by its teams and may be suspended or stopped if it does not meet the requirements necessary for patient safety.
This article was co-authored by Alexis Vaujany.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, May 2020 Issue (Thomson Reuters)