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  • CHMP highlights: March 2023
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    MEDICINES |COMMITTEES

    CHMP highlights: March 2023

  • CHMP highlights: March 2023
    CHMP slider image
    MEDICINES |COMMITTEES

    CHMP highlights: March 2023

    EMA's human medicines committee (CHMP) recommended 9 new medicines for approval in the EU at its March 2023 meeting

  • Bimervax recommended for approval in the EU
    covid19 opinion
    COVID-19 |Vaccines

    Bimervax recommended for approval in the EU

  • Bimervax recommended for approval in the EU
    covid19 opinion
    COVID-19 |Vaccines

    Bimervax recommended for approval in the EU

    EMA recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) for use as a booster in people aged 16 years and above

  • First anniversary of DARWIN EU®
    DARWIN EU
    Real-world evidence |Regulatory

    First anniversary of DARWIN EU®

  • First anniversary of DARWIN EU®
    DARWIN EU
    Real-world evidence |Regulatory

    First anniversary of DARWIN EU®

    DARWIN EU® has completed its first studies, generating real-world evidence to support regulatory decision making. A call to onboard ten additional data partners in 2023 is now open

  • Achievements of the Regulatory Science Strategy
    Regulatory Science |Report

    Achievements of the Regulatory Science Strategy

  • Achievements of the Regulatory Science Strategy
    Regulatory Science |Report

    Achievements of the Regulatory Science Strategy

    EMA published a report summarising the mid-term achievements of the Regulatory Science Strategy to 2025

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Latest news

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    31/03/2023

    Regulatory information – adjusted fees for applications to EMA from 1 April 2023

    The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2023. Every year, the European...

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    31/03/2023 COVID-19

    Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023

    Nine new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its March 2023 meeting. The CHMP recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA)...

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    30/03/2023 COVID-19

    EMA recommends approval of Bimervax as a COVID-19 booster vaccine

    EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years and above who have been vaccinated with an mRNA COVID-19 vaccine. Bimervax,...

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    28/03/2023

    DARWIN EU® has completed its first studies and is calling for new data partners

    DARWIN EU® , the Data Analysis and Real-World Interrogation Network, has accomplished its first year of establishment. Following the set-up of the DARWIN EU® Coordination Centre in February 2022, the first ten data partners were onboarded. The...

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    24/03/2023

    Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023

    CVMP opinions on veterinary medicinal products Under Regulation (EC) No 726/2004 The Committee adopted by consensus a positive opinion for a marketing authorisation of Newflend ND H9, from Ceva-Phylaxia Co. Ltd., a new vaccine for the active...

  • List item
    22/03/2023

    Advancing regulatory science in the EU – mid-point report published

    EMA has published a report summarising the mid-term achievements of its Regulatory Science Strategy (RSS) to 2025 . The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human and...

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