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Increase in vaccine manufacturing capacity
COVID-19 |VaccinesIncrease in vaccine manufacturing capacity
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Increase in vaccine manufacturing capacity
COVID-19 |VaccinesIncrease in vaccine manufacturing capacity
EMA’s human medicines committee (CHMP) has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU
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Monthly safety updates for COVID-19 vaccines
COVID-19 |VaccinesMonthly safety updates for COVID-19 vaccines
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Monthly safety updates for COVID-19 vaccines
COVID-19 |VaccinesMonthly safety updates for COVID-19 vaccines
Regular safety update reports on all authorised COVID-19 vaccines provide an overview of the ongoing safety monitoring
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Annual report 2020
EMA |About usAnnual report 2020
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Annual report 2020
EMA |About usAnnual report 2020
EMA’s Annual Report 2020 provides an overview of the Agency’s major achievements, key figures and contributions to public health in Europe. #AnnualReportEMA
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CTIS Sponsor Handbook
Clinical trials |RegulatoryCTIS Sponsor Handbook
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CTIS Sponsor Handbook
Clinical trials |RegulatoryCTIS Sponsor Handbook
This compilation of key guidance, technical information, recommendations and references will help clinical trials sponsors to get ready for the use of the Clinical Trial Information System (CTIS). #CTIS4EU
Latest news
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List item24/08/2021 COVID-19
Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna
EMA’s human medicines committee (CHMP) has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. Additional manufacturing site and scaled-up process for Comirnaty CHMP has approved an additional...
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List item16/08/2021 COVID-19
EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19
EMA has started evaluating the anti-inflammatory medicine RoActemra (tocilizumab) to extend its use to include treatment of hospitalised adult patients with severe COVID-19 who are already receiving treatment with corticosteroids and require extra...
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List item16/08/2021
Artificial intelligence in medicine regulation
The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators to address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in a report published...
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List item06/08/2021 COVID-19
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021
COVID-19 Vaccine Janssen: update on safety issues The PRAC recommended updating the product information of COVID-19 Vaccine Janssen to include immune thrombocytopenia as an adverse reaction, as well as a warning to alert healthcare professionals and...
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List item06/08/2021
Interoperability of track and trace systems: key to public health protection
EMA has endorsed recommendations developed by the International Coalition of Medicines Regulatory Authorities (ICMRA) to facilitate the use of track and trace systems at the global level. The paper published today identifies common technical...
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List item04/08/2021 COVID-19
ECDC and EMA update on COVID-19
Full vaccination is key to protecting against serious COVID-19, including disease caused by the Delta variant With the increasing circulation of the Delta variant of SARS-CoV-2 in EU/EEA countries, the European Medicines Agency (EMA) and the...
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