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The EU HTA Regulation Is Reshaping How Clinical Evidence Supports Market Access Across Europe
On 30 April 2026, a milestone quietly passed that will redefine how innovative medicines reach patients across the European Union. The HTA Coordination Group (HTACG) approved the very first Joint Clinical Assessment (JCA) report in history — covering tovorafenib (Ojemda®), Ipsen's treatment for paediatric low-grade malignant glioma. Completed well within the 30-day timeline from marketing authorisation, it marked the first real-world product of a regulatory and market access
Jul 2814 min read
Joint Scientific Consultations (JSCs): What They Are and Who They Can Help
If you have spent any time navigating the EU Health Technology Assessment (HTA) landscape in 2025 or 2026, you will have encountered a question that stops many development teams in their tracks: how do we design a clinical trial that satisfies both the EMA for marketing authorisation and EU HTA bodies for the Joint Clinical Assessment — when their evidence requirements do not always align? The answer, in regulatory terms, is the Joint Scientific Consultation (JSC) — one of
Jul 816 min read