COVID-19 guidance: evaluation and marketing authorisation
The European Medicines Agency (EMA) assesses applications for COVID-19 medicines under the minimum timeframe necessary to allow for a thorough evaluation of the medicine’s benefits and risks. Dedicated guidance and rapid procedures are available.
EMA rapid procedures can accelerate every step of the regulatory pathway while ensuring that robust evidence on efficacy, safety and quality is generated to support scientific and regulatory decisions.
They are available for initial marketing-authorisation applications for the treatment or prevention of COVID-19, as well as for applications to ‘repurpose’ medicines already authorised for other conditions, by extending their indications to include COVID-19.
|PROCEDURE AND REGULATORY TOOLS||FEATURES|
For more information see Accelerated assessment
|Conditional marketing authorisation|
For more information see Conditional marketing authorisation
EMA is ready to apply further flexibility, where it is established that shortening of any other procedural step could have an important public-health impact in dealing with the COVID-19 pandemic.
In addition, EMA will substantially accelerate the linguistic review process for procedures related to COVID-19.
It will also keep the European Commission informed about COVID-19-related applications to help speed up decisions on authorisations.
EMA encourages developers of potential vaccines to take these considerations into account when planning their strategy for applying for marketing authorisation.
EMA and the Heads of Medicines Agencies (HMA) also encourage developers to submit applications for EU marketing authorisation via EMA. This is the case even for vaccines that do not fall under the centralised procedure’s mandatory scope.
This aims to ensure that COVID-19 vaccines reach all EU Member States at the same time.
For more information, see:
Guidance is available on flexibilities to help developers of COVID-19 vaccines prepare and roll out packaging and labelling for their vaccines quickly. It includes practical advice on exemptions to some requirements that are possible, while keeping in line with regulatory requirements:
The guidance aims to facilitate the large-scale and rapid deployment of COVID-19 vaccines within the EU.
It provides details further to the European Commission's memorandum of Understanding (MoU) with Member States on regulatory flexibility for COVID-19 vaccines.
For more information, see:
Guidance is available for developers planning to adapt COVID-19 vaccines to address SARS-CoV-2 variants.
CHMP expects new ‘variant’ vaccines to largely rely on the same technologies and platforms as their ‘parent’ vaccine, but with a different antigen selected to trigger the immune response. The parent would be a vaccine already approved in the EU to prevent COVID-19.