Rare Insights

Exploring the ideas, innovations, and individuals shaping the future of rare disease.

EU JCA 2025 Explained: What Rare Disease Sponsors Need to Know Now

The EU Joint Clinical Assessment (JCA) is one of the most significant changes to hit market access in years.[…]

Patient experience data is now core evidence for the Joint Clinical Assessment

The EMA’s Reflection Paper published in September 2025 confirms an important shift. Patient experience data is no[…]

JCA is underway…what it really means for rare disease evidence

Introduction This article first appeared in the Rare Focus newsletter on LinkedIn (October 2025). The EU Joint Clinical[…]

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