This white paper examines the implementation of the EU Health Technology Assessment (HTA) Regulation and its implications for pharmaceutical and MedTech companies operating in Europe. It explains how joint clinical assessments will reshape evidence submission, timelines, and stakeholder engagement across member states. The paper highlights challenges in aligning global development programs with evolving EU evidentiary standards, particularly around endpoints, comparators, and real-world evidence. It outlines readiness strategies, including early evidence planning, cross-functional coordination, and scenario modeling. The report concludes that proactive alignment with EU HTA requirements is critical to reducing access delays and maximizing the value of innovation.

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