Europe’s shift to patient evidence: what it means for JCA and rare-disease sponsors
What is changing in Europe’s approach to patient evidence? Recent guidance, including the EMA Reflection Paper on[…]
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.[…]
EU Joint Clinical Assessment: What Sponsors Need to Know in 2025
The Joint Clinical Assessment (JCA) came into force in January 2025. It begins with oncology and advanced therapies and[…]
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[…]
From family to framework: how SLC6A1 Connect UK-AQ is reshaping collaboration in rare epilepsy
When Lindsay Randall’s son Arthur was diagnosed in 2018 with SLC6A1 Developmental and Epileptic Encephalopathy, there were[…]
AI, Rare Disease Research, and the Risks of “Synthetic Patients”
Artificial intelligence (AI) is beginning to find its place in rare disease research. With small populations, fragmented[…]
5 Misconceptions About Patient Engagement in JCA – And Why Early Access Could Be Your Advantage
As EU HTA evolves under the Joint Clinical Assessment (JCA), the expectations for structured, regulator-ready patient engagement[…]
5 Patient Evidence Myths That Could Undermine Your EU JCA Strategy
The bar for patient evidence in EU health technology assessment (HTA) is rising fast. As the Joint Clinical[…]