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HTA Quarterly Spring 2025

In this edition, following the implementation of the European Union (EU) Regulation on Health Technology Assessment (HTAR) for medicinal products in January, we review current processes and prepare for upcoming guidance for medical devices. We also discuss the value of early network mapping in systemic literature reviews (SLRs) for health technology assessment (HTA) submissions and spotlight the improved drug pricing environment in Japan, a result of positive changes to the pricing system adopted in April 2024.

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Rising sun: the drug pricing environment in Japan is on the up

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Early network mapping to guide HTA literature reviews—how do we identify the right evidence efficiently?
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The era of EU HTA has officially begun—but how will medical devices be affected?

Heard on the street

“EMA welcomes the new HTA regulation and is ready to do what it takes to support the European Commission and the Member States in its successful implementation.”

– EMA’s Executive Director, Emer Cooke, on the implementation of the new Regulation on Health Technology Assessment (HTAR) that became applicable in January 2025

Source: New EU rules for health technology assessments become effective

By the numbers

25
Number of joint clinical assessments (JCAs) the Member State Coordination Group on Health Technology Assessment (HTACG) estimates it will initiate in 2025. Of the 25, 17 JCAs are for medicinal products with new active substances in cancer treatment, and eight JCAs are for advanced therapy medicinal products (ATMPs).

Source: HTACG Annual Work Programme 2025 
 

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