COVID-19

COVID-19 guidance: assessment and marketing authorisation

Rapid procedures
Marketing authorisation guidance for COVID-19 vaccines
Labelling flexibilities for COVID-19 vaccines

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.

Rapid procedures

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 and extension applications for authorised medicines that are being re-purposed for the treatment of COVID-19.

PROCEDURE AND REGULATORY TOOLS	FEATURES
Rolling review	EMA's scientific committees (Committee for Medicinal Products for Human Use (CHMP) and Pharmacovigilance Risk Assessment Committee (PRAC)), with the support of the COVID-ETF, review data as they become available on a rolling basis, while development is still ongoing Several rolling review cycles can be carried out during the evaluation of one product as data continue to emerge, with each cycle lasting a minimum of two weeks depending on the amount of data to be assessed Each submission occurs in eCTD format. In addition to the newly available data, this would normally include also an application form, Module 2 overview(s) and responses to all outstanding questions from previous review cycles Once the data package is complete, the developer submits a formal marketing authorisation application which is then processed 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 (new)	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

PROCEDURE AND REGULATORY TOOLS

FEATURES

Rolling review

EMA's scientific committees (Committee for Medicinal Products for Human Use (CHMP) and Pharmacovigilance Risk Assessment Committee (PRAC)), with the support of the COVID-ETF, review data as they become available on a rolling basis, while development is still ongoing
Several rolling review cycles can be carried out during the evaluation of one product as data continue to emerge, with each cycle lasting a minimum of two weeks depending on the amount of data to be assessed
Each submission occurs in eCTD format. In addition to the newly available data, this would normally include also an application form, Module 2 overview(s) and responses to all outstanding questions from previous review cycles
Once the data package is complete, the developer submits a formal marketing authorisation application which is then processed 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 (new)

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

Applicants should email 2019-ncov@ema.europa.eu with:

a justification for assessing the product via a rapid procedure;
data supporting the proposed role of the product in the COVID 19 setting;
data supporting proof of concept.

Applicants can submit it together or after the request for eligibility to the centralised procedure.

: See accelerated assessment for how to apply.

: See conditional marketing authorisation for how to apply.

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.

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:

List item

EMA considerations on COVID-19 vaccine approval (PDF/205.33 KB)

Adopted

First published: 19/11/2020
EMA/592928/2020

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

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:

List item

Questions and answers on labelling flexibilities for COVID19 vaccines (PDF/187.74 KB)

First published: 27/11/2020
Last updated: 16/12/2020
EMA/470525/2020 Rev. 1

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 Product-information requirements

COVID-19 guidance: assessment and marketing authorisation

Table of contents

Rapid procedures

Marketing authorisation guidance for COVID-19 vaccines

EMA considerations on COVID-19 vaccine approval (PDF/205.33 KB)

Labelling flexibilities for COVID-19 vaccines

Questions and answers on labelling flexibilities for COVID19 vaccines (PDF/187.74 KB)

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