We are halfway through the preparatory phase of the European Union Health Technology Assessment Regulation – a phase due to close in January 2025. Member states and health sector stakeholders involved in the planning have made progress since the kick-off point in January 2022. Nonetheless, there is still considerable uncertainty for market access and the health economics and outcomes research industry to consider and navigate ahead of the 2025 deadline.

In this whitepaper, published halfway through the preparatory phase running from January 2022 to January 2025, we summarize what we know of the EU HTA Regulation so far, and consider some of the uncertainties that remain.

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