Europe and UK

Europe (EMA)

 Agency Web SIte (EMA)


FRP Detail Summaries

 

EMA Accelerated Assessment

    EMA Adaptive Pathway (regulatory HTA parallel advice)

    EMA Advanced Therapy Medicinal Product

    EMA Article 58

    EMA Conditional Marketing Authorization

    EMA Exceptional Circumstances

    EMA Orphan Designation

 EMA PRIME


FRP Flow Chart

Switzerland

 Agency Web SIte (Swissmedic))

MAGHP FRP Detail Summaries

 FRP Flow Chart

England

 Agency Web SIte (MHRA)

 FRP Detail Summaries

 FRP Flow Chart

Download FRPs

PRIME FRP detail 28Aug2019 (pdf)

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