Coronavirus - Derogation for COVID-19 clinical trials of medicinal products containing or consisting of genetically modified organisms

Source: FAMHP

August 19, 2020

In the context of the COVID-19 crisis, the European Union adopted a regulation providing for a temporary derogation from European legislation on genetically modified organisms.

In the context of the SARS-CoV-2 pandemic (COVID-19), the European Union (EU) has adopted the Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020. This regulation concerns the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms (GMOs) for the treatment or prevention of SARS-CoV-2 infection and the provision of these medicinal products. Read more.