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  • 1.  Orphan Drug Designation in US and EU

    Posted 19-Feb-2020 09:09
    We have orphan drug designation in US and now want to pursue obtaining the same designation in EU.  Where is the best place to start?

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    Erika Butler
    San Antonio TX
    United States
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  • 2.  RE: Orphan Drug Designation in US and EU

    Posted 20-Feb-2020 08:20
      |   view attached
    EMA has similar regulations for orphan drug designation, but of course are unique to the European environment. This is the best place to start.  

    https://www.ema.europa.eu/en/human-regulatory/overview/orphan-designation-overview

    You may also find the attached Pink Sheet article to be useful.

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    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
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    Original Message


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