Following a public consultation period, the Regulation on Health Technology Assessment (HTA) has been officially published and entered into force.

The new rules establish a permanent EU framework for the joint clinical assessment of health technologies, such as medicines and medical devices. By encouraging collaboration between Member States, the Regulation will support quicker and more consistent decision-making on pricing and reimbursement at national level, ultimately benefitting both patients and developers. The Regulation introduces:

• A single EU-level submission file for joint clinical assessments, avoiding duplication at national level and increasing scientific quality;
• Time-bound procedures, requiring assessments to be completed within 30 days of a medicine’s authorisation;
• Involvement of clinicians and patients, ensuring that their perspectives inform assessments. In fact, the experts’ panel for consultation during the clinical assessment process includes the European Reference Networks for rare and complex diseases, along with their respective European patient advocacy groups and the portal for rare diseases and orphan drugs.

Starting from January 2025, these new rules apply to marketing authorisation applications for a new cancer medicine or an Advanced Therapy Medicinal Product (ATMP). Then, they will be gradually expanded to high-risk medical devices (from 2026), orphan medicines (from 2028), and finally to all new medicinal products by 2030.