The authorization, in an accelerated procedure, comes from a recommendation from the European Medicines Agency (EMA), followed by an approval from the Member States.
“Protecting public health is a key priority of the EC and, as such, Remdesivir data were evaluated in an exceptionally short timeframe through a continuous examination procedure, an approach used by the EMA in public health emergencies to assess data as it becomes available, ”the EC was quoted as saying by Mediafax.
This allowed the authorization to be granted quickly in the context of the coronavirus crisis, within one week of the EMA recommendation, compared to the usual 67-day deadline.
Health and Safety Commissioner Stella Kyriakides said the authorization of a first drug to treat COVID-19 is a big step forward in the fight against the new coronavirus.
“We grant this authorization less than one month after the application is submitted, clear evidence of the EU ‘s determination to respond quickly whenever new treatments become available. We will spare no effort to provide effective treatments or vaccines against coronavirus, “said Kyriakides.
Authorized Remdesivir now has a conditional marketing authorization, one of the EU’s regulatory mechanisms designed to facilitate rapid access to medicines that meet an unmet medical need, including those for emergencies in response to health threats. such as the current pandemic.
Edited by Georgiana Marina