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European Generic Markets: Regulatory Approaches Across the EU in 2025

European Generic Markets: Regulatory Approaches Across the EU in 2025

  • December 11, 2025
  • Kiera Masterson

The EU's generic drug approval system is complex and changing fast in 2025. Four pathways, new rules on data protection, and national differences create both opportunities and barriers for manufacturers trying to bring affordable medicines to patients.

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