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Unmet medical need - European Medicines Agency

    https://www.ema.europa.eu/en/documents/presentation/presentation-defining-unmet-medical-need-jstokx_en.pdf
    “Unmet medical needs means a condition for which there exists no satisfactory method of diagnosis, prevention or treatment in the Union or, even if such a method exists, in relation to which the medicinal product concerned will be of major therapeutic …

Fast track routes for medicines that address unmet …

    https://www.ema.europa.eu/en/news/fast-track-routes-medicines-address-unmet-medical-needs
    The European Medicines Agency (EMA) has revised its guidelineson the implementation of accelerated assessmentand conditional marketing authorisation, two key tools in the …

Unmet medical need; definitions and need for clarity

    https://www.ema.europa.eu/en/documents/presentation/presentation-unmet-medical-need-j-llinares-ema_en.pdf
    •unmet medical need definition concept “borrowed” from CMA and applied in context of fostering accelerated assessment . Paediatric investigation plans •Can be waived if the …

Unmet medical need - European Medicines Agency

    https://www.ema.europa.eu/en/documents/presentation/presentation-unmet-medical-need-introduction-definitions-stakeholder-perceptions-jllinares-garcia_en.pdf
    Need to find a balance between the encouragement of early patient access and promoting increased certainty considering the benefits and harms . Challenge from . regulatory and …

PRIME: priority medicines | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines
    PRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. …

PRIority MEdicines (PRIME) - European Medicines …

    https://www.ema.europa.eu/en/documents/presentation/presentation-priority-medicines-prime-support-development-priority-medicines-unmet-medical-needs_en.pdf
    Unmet medical need, seriously debilitating or life-threatening disease, a rare disease or use in emergency situations. Early approval of a medicine on the basis of less complete …

Conditional marketing authorisation

    https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation
    EMA publishes the conditions of the marketing authorisation in the medicine's European public assessment report. The marketing authorisation can be converted into a standard marketing …

Unmet Medical Need: An Introduction to Definitions and …

    https://pubmed.ncbi.nlm.nih.gov/31708064/
    Background: Despite increasing informal and formal use of unmet medical need (UMN) in drug development, regulation, and assessment, there is no insight into its definitions …

Toolbox guidance on scientific elements and …

    https://www.ema.europa.eu/en/documents/scientific-guideline/toolbox-guidance-scientific-elements-regulatory-tools-support-quality-data-packages-prime-certain_en.pdf
    The EMA launched the PRIME scheme to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on …

Expedited Regulatory Pathways for …

    https://globalforum.diaglobal.org/issue/september-2018/expedited-regulatory-pathways-in-established-and-emerging-markets/
    In Mexico, “equivalence agreements” provide the benefit of moving approval times from nine months to three to four months; the regulatory authority in Mexico (COFEPRIS) approves applications for …



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