The European Commission granted a conditional marketing authorisation for the medicine Remdesivir, making it the first medicine authorised at EU level for treatment against COVID-19. This authorisation, under an accelerated procedure, comes after a recommendation by the European Medicines Agency (EMA), followed by an endorsement by the Member States.
The protection of public health is a key priority of the Commission, and as such, the data on Remdesivir were assessed in an exceptionally short timeframe through a rolling review procedure, an approach used by EMA during public health emergencies to assess data as they become available. This has enabled the authorisation to be granted quickly in the context of the coronavirus crisis, within one week after EMA’s recommendation, compared to the usual 67 days.
Stella Kyriakides, Commissioner for Health and Food Safety, said: “Today’s authorisation of a first medicine to treat COVID-19 is an important step forward in the fight against this virus. We are granting this authorisation less than a month after the application was submitted, showing clearly the EU’s determination to respond quickly whenever new treatments become available. We will leave no stone unturned in our efforts to secure efficient treatments or vaccine against the coronavirus.”
Remdesivir is now authorised for a conditional marketing authorisation, one of the EU regulatory mechanisms created to facilitate early access to medicines that fulfil an unmet medical need, including those for emergency situations in response to public health threats such as the current pandemic.