New European Union’s Health Technology Assessment (EU HTA) regulation
- Healthcare and General Service
- February 14, 2025
Highlights
- The EU Commission has established Regulation to standardise health technology assessment (HTA) and enhance the availability of innovative health technologies across the EU
- The HTAR, in force since February 2022, and four associated implementing regulations, came into effect in January 2025
Regulation (EU) 2021/2282 on health technology assessment (HTA) came into effect on January 12th, 2025, marking a significant milestone in the European Union’s approach to evaluating health technologies. The legislation aims to streamline cooperation among EU Member States and create a unified framework for assessing various health technologies.
The HTA Regulation introduces the Joint Clinical Assessment (JCA) process, focusing on clinical evaluation of new technologies. This process aims to reduce duplication of efforts, optimise resources, and provide quicker access to innovative healthcare solutions across the EU.
The new regulation streamlines EU-level clinical assessments by pooling resources through a single submission file, which ensures quicker access to critical medicines for patients in need, and prioritising patient perspectives throughout the assessment process, thereby streamlining the evaluation process.
New rules for new cancer medicines and advanced therapy medicinal products will be initially introduced, with the scope expanding to include orphan medicines by 2028.
