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Full assessment report available for first authorised COVID-19 vaccine
COVID-19 |VaccineFull assessment report available for first authorised COVID-19 vaccine
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Full assessment report available for first authorised COVID-19 vaccine
COVID-19 |VaccineFull assessment report available for first authorised COVID-19 vaccine
EMA has published the assessment report for Comirnaty, the first COVID-19 vaccine to be authorised in the EU, together with the product information in all official EU languages.
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Second public meeting on COVID-19 vaccines
COVID-19 |EVENTSecond public meeting on COVID-19 vaccines
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Second public meeting on COVID-19 vaccines
COVID-19 |EVENTSecond public meeting on COVID-19 vaccines
Apply now to ask a question during our virtual meeting on Thursday 8 January. The event will be broadcast, with updates on the assessment, approval and roll-out of COVID-19 vaccines.
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Management Board: Highlights of December 2020 meeting
Management Board |HighlightsManagement Board: Highlights of December 2020 meeting
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Management Board: Highlights of December 2020 meeting
Management Board |HighlightsManagement Board: Highlights of December 2020 meeting
The Board focused in particular on the Agency’s activities in response to the COVID-19 pandemic. It also adopted EMA’s budget for 2021.
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Development, evaluation and monitoring of COVID-19 vaccines
COVID-19 |VACCINESDevelopment, evaluation and monitoring of COVID-19 vaccines
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Development, evaluation and monitoring of COVID-19 vaccines
COVID-19 |VACCINESDevelopment, evaluation and monitoring of COVID-19 vaccines
Read about how EMA is ensuring vaccines for COVID-19 meet the highest standards of quality, safety & efficacy while their development and approval is sped up due to the public health emergency.
Latest news
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List item23/12/2020
IT systems temporarily unavailable from 31 December 2020 to 1 January 2021
Several European Medicines Agency (EMA) information technology (IT) systems will be temporarily unavailable between 08:00 on Thursday 31 December 2020 and 18:00 on Friday 1 January 2021 (Central European Time, CET). This is due to essential...
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List item22/12/2020 COVID-19
EMA organises a second public meeting about the new COVID-19 vaccines
EMA will organise a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines. Together with the EU medicines regulatory network, EMA has been working around the clock to...
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List item22/12/2020
Cyberattack on EMA - update 3
The ongoing investigation of the cyberattack on EMA, carried out by the Agency in close collaboration with law enforcement and other relevant entities, has revealed that the data breach was limited to one IT application. The perpetrators primarily...
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List item21/12/2020 COVID-19
EMA recommends first COVID-19 vaccine for authorisation in the EU
Update: Comirnaty is now authorised across the EU. This follows the granting of a conditional marketing authorisation by the European Commission on 21 December 2020. EMA has recommended granting a conditional marketing authorisation for the vaccine...
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List item18/12/2020
Cyberattack on EMA - update 2
EMA has engaged a specialised third-party service provider to support the full investigation that is currently being carried out in close cooperation with law enforcement and other relevant entities. This company will contribute to the additional...
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List item18/12/2020 COVID-19
EMA Management Board: highlights of December 2020 meeting
The December 2020 meeting of the Management Board was Emer Cooke’s first Board meeting as EMA's Executive Director since she took up leadership of EMA in November. Update on COVID-19 The Management Board was updated that evaluation of applications...
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Account Management portal
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eSubmission
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EudraVigilance (human)
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EU Veterinary Medicinal Product Database
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European Vaccination Information Portal