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  • CHMP highlights: July 2023
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    MEDICINES |COMMITTEES

    CHMP highlights: July 2023

  • CHMP highlights: July 2023
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    MEDICINES |COMMITTEES

    CHMP highlights: July 2023

    EMA's human medicines committee (CHMP) recommended 14 new medicines for approval in the EU at its July 2023 meeting

  • Use of artificial intelligence in medicines’ lifecycle
    Reflection paper artificial intelligence slider
    Artificial intelligence |Regulatory

    Use of artificial intelligence in medicines’ lifecycle

  • Use of artificial intelligence in medicines’ lifecycle
    Reflection paper artificial intelligence slider
    Artificial intelligence |Regulatory

    Use of artificial intelligence in medicines’ lifecycle

    Draft reflection paper for public consultation on regulators’ views on artificial intelligence for the development, use and regulation of human and veterinary medicines

  • EU steps up action to prevent shortages of antibiotics
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    Antibiotics |Shortages

    EU steps up action to prevent shortages of antibiotics

  • EU steps up action to prevent shortages of antibiotics
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    Antibiotics |Shortages

    EU steps up action to prevent shortages of antibiotics

    Joint statement from EMA, the European Commission and the Heads of Medicines Agencies (HMA)

  • Safety review ongoing for GLP-1 receptor agonists
    Slider image for ongoing safety review of GLP-1 receptor agonists
    Medicines |Safety

    Safety review ongoing for GLP-1 receptor agonists

  • Safety review ongoing for GLP-1 receptor agonists
    Slider image for ongoing safety review of GLP-1 receptor agonists
    Medicines |Safety

    Safety review ongoing for GLP-1 receptor agonists

    EMA’s safety committee, the PRAC, is reviewing data on the risk of suicidal thoughts with medicines used for weight loss and for treating type 2 diabetes

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Latest news

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    21/07/2023 COVID-19

    Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2023

    14 new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its July 2023 meeting. The CHMP recommended granting a marketing authorisation for Abrysvo (bivalent, recombinant), a vaccine...

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    21/07/2023

    First RSV vaccine to protect infants up to 6 months of age and older adults

    EMA has recommended granting a marketing authorisation in the European Union (EU) for Abrysvo , a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is the first RSV vaccine indicated for passive immunisation...

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    20/07/2023

    OPEN framework extended to a wider range of medicines

    EMA has expanded the scope of the OPEN initiative from COVID-19 vaccines and treatments to a wider range of medicines, such as medicines with the potential to address antimicrobial resistance (AMR), respiratory syncytial virus (RSV) infections or...

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    19/07/2023

    Reflection paper on the use of artificial intelligence in the lifecycle of medicines

    EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. This paper, which is now open...

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    17/07/2023

    European Health Union: EU steps up action to prevent shortages of antibiotics for next winter

    The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency are today issuing recommendations for actions to avoid shortages of key antibiotics used to treat respiratory infections for European patients in the...

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    14/07/2023

    Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 July 2023

    CVMP opinions on veterinary medicinal products Under Regulation (EU) 2019/6, the Committee adopted, by consensus, a positive opinion for a marketing authorisation for Yurvac RHD , from Laboratorios Hipra, S.A., a new vaccine for the active...

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