Tag: DARWIN EU

  • EMA and EU-HTA Alignment: One Evidence Strategy for Regulatory Approval and JCA

    EMA and EU-HTA Alignment: One Evidence Strategy for Regulatory Approval and JCA

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    EMA and EU-HTA Alignment Building One Evidence Strategy for Regulatory Approval and Joint Clinical Assessment Europe’s evidence environment has entered a new phase. A medicine can now move through the European Medicines Agency’s regulatory assessment while, in parallel, entering the EU-level Joint Clinical Assessment process. These procedures remain legally and methodologically distinct, but manufacturers must…