Regulatory & compliance

Global Impact of Covid-19 coronavirus on “non-Covid” clinical trials

Zara Sproul

In recent weeks and months, the life sciences sector has been the focal point of efforts to respond to the Covid-19 threat.  While these efforts have – justifiably – occupied many of the headlines, this blog post looks at the impact of the pandemic on “non-Covid” focused clinical trials and steps taken to limit disruption Read More

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

Belgium – Covid-19 coronavirus: measures affecting the life sciences sector

Tine Carmeliet

In the fight against the Covid-19 coronavirus pandemic, the Belgium government has taken several exceptional measures, including (i) restricting the sale of certain medical devices and personal protective equipment; (ii) issuing a Guideline for the reuse of surgical masks and FFP2/FFP3 masks; and (iii) communicating on how Covid-19 tests should be made available in Belgium. 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