France

France – Update of national early meetings guide for medicines evaluation

Jeanne Fabre

On 29 April 2020, the French High Health Authority (HAS) updated its guide on national early meetings for medicines evaluation. As part of its action plan for innovative medicines and its work programme presented at the beginning of 2020, the HAS has revised its guide to early meetings which aims to support businesses in the Read More

Covid-19 coronavirus: French High Health Authority publishes position on the use of rapid serological tests

Jeanne Fabre

Further to publishing evaluation criteria for serological tests for antibodies against SARS-CoV-2 (available here), the French High Health Authority (HAS) published on 18 May 2020 its opinion on the use of rapid serological tests (including self-tests) and an educational paper on Covid-19 coronavirus serological tests. The HAS indicated that while all serological tests used for Read More

Start of French medical cannabis pilot programme postponed to January 2021

Eveline Van Keymeulen

Today, the French Medicines Agency (ANSM) and the Health Ministry published an update on the continuance of the work of the Scientific Committee (CST) with respect to the French medical cannabis pilot programme. The update confirms that, following the activities carried out since 2018, the Directorate General for Health (DGS) and the ANSM remain fully Read More

Covid-19 coronavirus: Update on and processes of the clinical trials on Covid-19 patients in France

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 Read More

Simplification of registration procedure for French person responsible for pharmacovigilance

Eveline Van Keymeulen

In February 2020, the French National Agency for Medicines and Health Products Safety (ANSM) announced that it had set up a new portal on its website, accessible from 1 March 2020, allowing the electronic registration of persons responsible for pharmacovigilance (RPVs) in France. The registration was previously carried out through email or post. Under Article Read More