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  • Increase in vaccine manufacturing capacity
    additional manufacturing capacity
    COVID-19 |Vaccines

    Increase in vaccine manufacturing capacity

  • Increase in vaccine manufacturing capacity
    additional manufacturing capacity
    COVID-19 |Vaccines

    Increase 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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    safety updates COVID-19
    COVID-19 |Vaccines

    Monthly safety updates for COVID-19 vaccines

  • Monthly safety updates for COVID-19 vaccines
    safety updates COVID-19
    COVID-19 |Vaccines

    Monthly safety updates for COVID-19 vaccines

    Regular safety update reports on all authorised COVID-19 vaccines provide an overview of the ongoing safety monitoring

  • Annual report 2020
    annual report 2020
    EMA |About us

    Annual report 2020

  • Annual report 2020
    annual report 2020
    EMA |About us

    Annual 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 Sponsors handbook
    Clinical trials |Regulatory

    CTIS Sponsor Handbook

  • CTIS Sponsor Handbook
    CTIS Sponsors handbook
    Clinical trials |Regulatory

    CTIS 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

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Latest news

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    24/08/2021 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...

  • List item
    16/08/2021 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...

  • List item
    16/08/2021

    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...

  • List item
    06/08/2021 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...

  • List item
    06/08/2021

    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...

  • List item
    04/08/2021 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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