Regulatory news
Regolamento HTA: rilasciato il Report on Emerging Health Technologies
The Subgroup for the identification of emerging health technologies of the Coordination Group on Health Technology Assessment (the ‘HTACG’) released a report on Emerging Health Technologies.
This report highlights new and emerging health technologies that may be relevant for JCAs starting in 2026.
Key Points:
- The report identifies innovative medical products and technologies likely to be considered for future EU HTA evaluations.
- Three main categories are covered:
- Medicinal Products (Oncology): 61 products with new therapeutic indications for cancer, including 6 with EMA PRIME designation and 21 orphan drugs.
- Advanced Therapy Medicinal Products (ATMPs): 25 ATMPs with new indications, 8 with PRIME status, and 7 orphan drugs.
- Medical Devices: 15 devices have received scientific advice from EMA and may be relevant for joint assessments from 2026.
- The report includes graphics showing the distribution of products by indication and regulatory status.
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