HTA: The new rules will initially apply to new active substances to treat cancer and to all advanced therapy medicinal products (ATMPs). They will be expanded to orphan medicinal products in January 2028, and to all centrally authorised medicinal products as of 2030. Selected high-risk medical devices will also be assessed under the HTAR as of 2026.
EMA now has a legal obligation to notify the European Commission, which serves as the secretariat to the HTA Coordination Group (HTACG), ensuring that procedures are followed and joint work is produced in a timely and transparent manner when it receives submissions for marketing authorisation applications for medicinal products in the scope of JCA. From June 2024, the Agency started identifying such applications.
Based on anticipated marketing authorisation applications to EMA and health technology developers’ submission plans, the HTACG estimates that it will need to conduct 17 JCAs for cancer medicines and 8 JCAs for ATMPs in 2025. Cancer-related ATMPs are included in the cancer medicines count.
https://www.ema.europa.eu/en/news/new-eu-rules-health-technology-assessments-become-effective