The way health technology assessments (HTAs) are conducted in Europe is undergoing a significant
transformation. Starting next year, all new advanced therapeutic products and oncology drugs will be subject to a mandatory, EU-wide joint clinical assessment (JCA). By 2030, this will extend to orphan drugs, class IIb or III medical devices, and class D in vitro diagnostic devices.
This shift aims to enhance access to new products by streamlining the nation-specific approach currently in place for post-regulatory approval adoption. The EU HTA regulation represents one of the most substantial overhauls in decades. Organizations that proactively address the associated challenges can benefit substantially in the long run.
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