Article
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.
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
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
Source: HTACG Annual Work Programme 2025
