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Keryx Biopharmaceuticals Inc. Message Board

  • kolemup kolemup Jan 7, 2014 4:48 PM Flag

    The key for Zerenex Rejection spelled bellow in official wording...

    Summary / Conclusions
    • Drug development in Japan need not be complicated or
    mysterious
    – Regulations are different, but regulators have flexibility
    – High degree of collaborati
    on between agency/ministry,
    physicians, patients and industry is feasible
    – Agents with strong science or clinical need receive attention
    • Because of differences between Japan versus US/EU,
    good understanding of the Japanese regulations can
    lead to commercialization advantages and opportunities
    – Drugs available elsewher
    e but not approved in Japan
    • Key: Close communication with both the PMDA and the
    MHLW
    – For foreign pharmaceutical/bio
    tech companies, a strong in-
    house Japanese regulatory affairs group or close working
    relationship with external consultants familiar with Japanese
    regulations is a must

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