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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
New PRIME Tools to Accelerate Development of Medicines in the EU: What It Means for Industry and Regulatory Careers
In March 2026, the European Medicines Agency (EMA) made a landmark announcement. After completing a two-year pilot programme, the agency formally launched three major new features under its PRIME (PRIority MEdicines) scheme — powerful tools designed to improve how innovative medicines reach patients across the European Union. For pharmaceutical developers, biotech companies, and the regulatory professionals who support them, this is not a routine administrative update. It rep
Jul 213 min read
From Hospital Pharmacy to the MHRA: How Jas Changed Her Career in Regulatory Affairs
Part of the Entry to Regulatory Success Stories Series Jas was a hospital pharmacist who felt stuck — until she discovered regulatory affairs. Here's how she made the leap to the MHRA, and what her journey can teach you. She Knew Medicines Inside Out. But the Industry Didn't Know Her. Jas had built her career in hospital pharmacy. Day after day, she worked at the intersection of medicines, patients, and clinical decision-making — reviewing prescriptions, counselling patie
Jun 198 min read