Health Technology Assessment (HTA) in Europe has undergone its biggest shake-up in a generation. Moving toward a centralized approach across its member states, the European Commission has implemented joint clinical assessment (JCA) of health technologies in the European Union (EU), fundamentally changing the way new medical advances and innovations are brought to market in the EU. From 12 January 2025 the EU HTA Regulation began to apply to new oncology products, advanced therapy medicinal products (ATMP), and selected medical devices. The Regulation will apply to other products based on an agreed timeline.
Standardizing HTA across 27 countries with a combined population of over 400 million people is unprecedented in history, and the path to this point has been complex and challenging. Lumanity has been tracking developments on the EU HTA Regulation since its inception, taking part in the public consultations and attending stakeholders’ meetings. Since then, we have been committed to expanding our experience by delivering an extensive range of EU HTA Regulation projects.
Contact us for support preparing for joint clinical assessment, from training programmes and business readiness plans, to PICO simulations, evidence generation, and dossier writing, our team is here to help.