Human regulatory

COVID-19

COVID-19 guidance: evaluation and marketing authorisation

Table of contents

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.  

Rapid procedures

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 TOOLSFEATURES
Rolling review
  • EMA's scientific committees - Committee for Medicinal Products for Human Use (CHMP) and Pharmacovigilance Risk Assessment Committee (PRAC) - review data as they become available on a rolling basis. This review is done with the support of the COVID-19 EMA pandemic Task Force (COVID-ETF).
  • The review takes place while development is still ongoing
  • The COVID-ETF has to agree on the start of a rolling review 
  • Several rolling review cycles can be carried out during the evaluation of one product while data continue to emerge. The number of cycles depends on the amount to be assessed
  • Each cycle is pre-agreed between EMA and the applicant
  • The submission for each cycle takes place in eCTD format.
  • In addition to the newly available data, each submission normally includes:
    • an application form
    • module 2 overview(s)
    • responses to all outstanding questions from previous review cycles
  • During the rolling review, EMA assess whether the data package is complete enough to invite the applicant to submit a formal marketing authorisation application. In these cases, EMA processes the application under a shortened timetable
Accelerated assessment
  • Can be considered for medicines and vaccines not undergoing a rolling review
  • Requires a complete application to be available at the time of submission (unlike a rolling review)
  • Review is reduced to 150 days (from 210 days) or less after validation of a complete application

For more information see Accelerated assessment

Conditional marketing authorisation
  • Is a regulatory tool to fast track medicines for use in emergency situations by granting a marketing authorisation as soon as sufficient data becomes available to demonstrate that the benefits outweigh the risks
  • Ensures that the medicine is manufactured and controlled according to high pharmaceutical standards compatible with large scale commercialisation
  • Once a it has been granted, companies must provide further data from ongoing or new studies within pre-defined deadlines to confirm that the benefits continue to outweigh the risks
  • Is valid for one year and renewable

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.

Marketing authorisation guidance for COVID-19 vaccines

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:

    Labelling flexibilities for COVID-19 vaccines

    The regulatory flexibilities described in the guidance below are no longer granted. Those already granted, such as English-only labelling for COVID-19 vaccines, extend until the end of 2023 to ensure a smooth phase-out and avoid disruption. 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:

    Labelling flexibilities for COVID-19 treatments

    The regulatory flexibilities described in the guidance below are no longer granted. Those already granted, such as English-only labelling for COVID-19 vaccines, extend until the end of 2023 to ensure a smooth phase-out and avoid disruption. 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.

    For more information, see:

    Adapting COVID-19 vaccines to SARS-CoV-2 variants

    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:

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