COVID-19 guidance: evaluation and marketing authorisation
During the COVID-19 public health emergency, the European Medicines Agency (EMA) assessed applications for COVID-19 medicines under the minimum timeframe necessary to allow for a thorough evaluation of the medicine’s benefits and risks.
The guidance in this section was intended for use during the COVID-19 public health emergency. Some of it remains relevant, either for COVID-19 medicines or if another public health emergency were to happen. Please see individual topics for more information.
EMA rapid procedures helped 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 were 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
For more information, see the guidance below. EMA may use the approaches in this document if another public health emergency were to occur:
EMA applied further flexibility, where it 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 substantially accelerated the linguistic review process for procedures related to COVID-19.
It also kept the European Commission informed about COVID-19-related applications to help speed up decisions on authorisations.
Guidance is available for developers of potential COVID-19 vaccines on the clinical evidence to include in marketing authorisation applications.
The principles in this guidance remain relevant for COVID-19 vaccines after the pandemic:
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 was provided 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, while keeping in line with regulatory requirements:
The purpose of the guidance was 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 was provided on flexibilities to help developers of COVID-19 treatments prepare and roll out packaging and labelling for their treatments quickly.
It describes EMA’s criteria for deciding if a COVID-19 treatment could benefit from the same temporary labelling exemptions as COVID-19 vaccines.
Guidance is available for developers planning to adapt COVID-19 vaccines to address SARS-CoV-2 variants.
A reflection paper from EMA’s CHMP details the non‑clinical, clinical, quality and manufacturing data needed to support the approval of such adaptations in the EU.
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.
The principles in this guidance remain relevant for COVID-19 vaccines after the public health emergency:
Procedural guidance is also available on submitting a variation application to update the composition of an authorised COVID-19 vaccine to address SARS-CoV-2 variants. For more information: