The EU Health Technology Assessment (HTA) Regulation

Navigate the complex and evolving European HTA landscape with Lumanity

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.

According to a recent Lumanity survey on EU HTA Regulation preparedness...

67%

of survey respondents either did not know or were not sure how the new Regulation would affect their organization

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Nearly one-quarter

of survey respondents are facing internal obstacles as they try to prepare their organization for the new Regulation

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Only 33%

of survey respondents felt they knew enough about the new EU HTA Regulation

3 / 3

Prepare for the new Regulation with Lumanity

Start Preparing Now

Lumanity is already working with leading health technology developers on their readiness plans as the full implementation of the EU HTA Regulation draws closer. Take advantage of our deep knowledge and understanding of the Regulation’s implications, as well as the likely direction of travel as the Regulation continues to be rolled out.

Comprehensive Training Program

Lumanity has teamed up with independent HTA expert, Neil Grubert, to deliver a cross-functional training program that raises awareness and understanding of the EU HTA Regulation’s impact, as well as sharing some top tips to help you plan for the Regulation’s requirements. Contact us to find out more and to book your training.

What Clients are Saying

“Thank you for all your help and flexibility with us. We were really pleased to see the discussions and involvement of our colleagues on this topic thanks to your clear and insightful presentations.” - Director EU Government Affairs, Astellas Europe

Our Perspectives on the EU HTA Regulation

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