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  • 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

  • Management Board: Highlights of March 2023 meeting
    Management Board meeting highlights
    Management Board |Highlights

    Management Board: Highlights of March 2023 meeting

  • Management Board: Highlights of March 2023 meeting
    Management Board meeting highlights
    Management Board |Highlights

    Management Board: Highlights of March 2023 meeting

    The Board received updates on the Agency’s extended mandate and the recent operational experience with the clinical trials information system

  • Human medicines: highlights of 2022
    Medicines |Highlights

    Human medicines: highlights of 2022

  • Human medicines: highlights of 2022
    Medicines |Highlights

    Human medicines: highlights of 2022

    EMA recommended 89 human medicines for marketing authorisation in 2022. Check out our overview of key recommendations on the authorisation and safety monitoring of human medicines

  • Veterinary medicines: highlights of 2022
    Medicines |Highlights

    Veterinary medicines: highlights of 2022

  • Veterinary medicines: highlights of 2022
    Medicines |Highlights

    Veterinary medicines: highlights of 2022

    EMA recommended 10 veterinary medicines for marketing authorisation in 2022. Check out our overview of key recommendations on the authorisation and safety monitoring of veterinary medicines

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    03/02/2023

    Public consultation on a multi-stakeholder platform to improve clinical trials in the EU

    On 3 February 2023, EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching a public consultation on the establishment of a multi-stakeholder platform to improve clinical trials in the European Union (EU). The multi...

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    03/02/2023

    EMA Committee on Herbal Medicinal Products re-elects Emiel van Galen as Chair

    At its January 2023 meeting, EMA’s Committee on Herbal Medicinal Products (HMPC) re-elected Emiel Van Galen from the Botanicals and Novel Foods at the Medicines Evaluation Board (CBG-MEB) as its Chair for another three-year mandate. “The work of the...

  • List item
    31/01/2023

    Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU

    From 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). CTIS is now the single-entry point for sponsors and regulators of clinical trials for the...

  • List item
    27/01/2023

    Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023

    Four new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended granting a marketing authorisation for Sotyktu (deucravacitinib) for the treatment of moderate to severe plaque psoriasis in adults, a skin disease...

  • List item
    26/01/2023

    EMA Committee for Advanced Therapies elects Ilona Reischl as its new Chair

    At its January 2023 meeting, EMA’s Committee for Advanced Therapies (CAT) elected Ilona Reischl from the Austrian Medicines and Medical Devices Agency (AGES MEA) as its new Chair for a three-year mandate. Before becoming Chair, Dr Reischl served as...

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    26/01/2023

    EMA update on shortages of antibiotics in the EU

    EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met on Thursday to discuss the progress made and to agree on the next steps in the coordinated response to the ongoing shortages of antibiotic medicines containing...

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