Executive Summary
The introduction of the European Joint Clinical Assessment (JCA), a centralized EU process for the scientific analysis of clinical evidence on the relative effectiveness and safety of a health technology, marks a pivotal moment for drug launch in Europe. Beginning with oncology and advanced therapy medicinal products (ATMPs) from January 12, 2025, followed by orphan drugs in 2028, and ultimately extending to all centrally authorized medicines from January 2030.
While JCA promises harmonized clinical evidence assessment and the potential for more streamlined patient access, it also introduces new complexity and raises expectations for evidence planning and collaboration within manufacturers.
This white paper explores how companies can transform JCA from a regulatory and access challenge into a source of competitive advantage by focusing on three essential pillars: Culture, Collaboration, and Continuous Learning, the “3C’s” of JCA readiness.
Drawing on real-world insights from both our day-to-day project experience and the Partners4Access Access Summit, this paper provides actionable strategies to help organizations future-proof their market access in the evolving European.
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