JCA in the EU: A roadmap for health technology developers
The Joint Clinical Assessment (JCA) framework is transforming how new medicines are evaluated across the European Union. Implemented in January 2025 for oncology products and advanced therapy medicinal products, with orphan drugs following in 2028 and other products in 2030, this process creates a single harmonized clinical evidence evaluation for all 27 EU member states.
While JCA streamlines clinical assessments and promotes equitable access to innovative treatments, it can present challenges for health technology developers. Companies must navigate multiple PICOs across diverse healthcare systems, manage tight submission timelines, work with limited stakeholder interaction opportunities, and integrate JCA outcomes with national HTA processes.
Our roadmap highlights key areas of strategic focus for success in this new landscape. This includes early PICO scoping and prioritization, early integrated evidence planning, and effective engagement with key stakeholders.
Download our complete JCA roadmap now to gain valuable insights and actionable guidance for navigating this complex new framework and optimizing your product's path to European patients.
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