The EU Health Technology Assessment (HTA) Regulation
Health Technology Assessment (HTA) in Europe is undergoing its biggest shake-up in a generation. Moving toward a centralized approach across its member states, the European Commission will implement 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.
The “Regulation on Health Technology Assessment (HTA), Regulation (EU) 2021/2282” (EU HTA Regulation) entered into force on 11 January 2022. From 12 January 2025 it will apply to new oncology products, advanced therapy medicinal products (ATMP), and selected medical devices. The EU HTA Regulation will then 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 and our experts have built up a wealth of knowledge of the Regulation’s fundamentals.
Contact us for support preparing for the EU HTA Regulation’s full implementation, including our comprehensive training program.
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