Tag: EMA
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EU Pharma Package 2026: What Market Access Teams Should Prepare for Before Formal Adoption
EU Pharma Package 2026: What Market Access Teams Should Prepare for Before Formal Adoption Europe is approaching the most significant reform of its pharmaceutical legislation in more than two decades. Following the political agreement reached by the European Parliament and the Council in December 2025, the compromise texts for the revised EU pharmaceutical framework were…
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EMA and EU-HTA Alignment: One Evidence Strategy for Regulatory Approval and JCA
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…