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  • Supporting development of medicines for children
    EMA and EC joint action plan on paediatric medicines
    Paediatric |Report

    Supporting development of medicines for children

  • Supporting development of medicines for children
    EMA and EC joint action plan on paediatric medicines
    Paediatric |Report

    Supporting development of medicines for children

    An EMA and European Commission report highlights improvements, such a pilot on ‘stepwise’ paediatric investigation plans for certain medicines, brought by their 2018 action plan

  • Multi-stakeholder platform to improve clinical trials
    ACT EU 2022-2026 workplan
    Clinical trials |Regulatory

    Multi-stakeholder platform to improve clinical trials

  • Multi-stakeholder platform to improve clinical trials
    ACT EU 2022-2026 workplan
    Clinical trials |Regulatory

    Multi-stakeholder platform to improve clinical trials

    EMA, the Heads of Medicines Agencies and the European Commission are launching a public consultation on a multi-stakeholder platform aimed to improve clinical trials in the EU

  • New role for EMA during public health emergencies
    EMA extended mandate
    Extended mandate |Regulatory

    New role for EMA during public health emergencies

  • New role for EMA during public health emergencies
    EMA extended mandate
    Extended mandate |Regulatory

    New role for EMA during public health emergencies

    Additional responsibilities for monitoring and mitigation shortages of critical medical devices during public health emergencies now apply

  • CTIS now mandatory for new trial applications
    CTIS go-live slider
    Clinical trials |Regulatory

    CTIS now mandatory for new trial applications

  • CTIS now mandatory for new trial applications
    CTIS go-live slider
    Clinical trials |Regulatory

    CTIS now mandatory for new trial applications

    From 31 January 2023, all initial clinical trial applications in the European Union must be submitted via the Clinical Trials Information System (CTIS)

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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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    20/01/2023

    Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 17-18 January 2023

    CVMP opinions on veterinary medicinal products Under Regulation (EU) 2019/6 The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for: Suvaxyn Circo+MH RTU Galliprant Bovela...

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    20/01/2023

    Joint statement by Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on shortages of antibiotic medicines

    EMA, the European Commission and the Heads of Medicines Agencies (HMA) , through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , are closely monitoring and responding to current shortages of antibiotics affecting...

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    19/01/2023

    Assessment of human dietary exposure to residues of veterinary medicines in the EU

    EMA and the European Food Safety Authority (EFSA) have published a joint report on the development of a harmonised approach to the assessment of dietary exposure of people to residues of veterinary medicines, feed additives and pesticides in food of...

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    13/01/2023

    Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 January 2023

    Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors EMA’s safety committee, PRAC has further reviewed measures to minimise the risk of serious side effects associated with Janus kinase (JAK)...

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    21/12/2022

    End-of-year message from EMA’s Executive Director

    We are rapidly approaching the end of 2022 and the festive season, which for many of us is one of the most wonderful times of the year – mainly because we reunite with family and friends from near and far to celebrate, to embrace. This has become...

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