Tag: EU generic approval

European Generic Markets: How Regulatory Approaches Across the EU Shape Drug Access and Competition

European Generic Markets: How Regulatory Approaches Across the EU Shape Drug Access and Competition

The EU's generic drug approval system is complex, with four different pathways, each affecting how quickly and where a generic reaches patients. The 2025 reforms have changed data protection, launch timelines, and supply rules-shifting how manufacturers enter the market.

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