The EU’s new Regulation on Health Technology Assessment (HTA) is applicable from 12 January, helping ensure that innovative and effective health technologies are available to patients across the EU.
The new rules create an EU framework for the assessment of health technologies, such as medicines and medical devices, by fostering collaboration and coordination between the EU Member States. This is aimed at helping national authorities make more timely and informed decisions on the pricing and reimbursement of health technologies and streamline the procedure for health technology developers. This would contribute to faster and wider access to new and more effective innovative products for patients.
The rules will apply to companies seeking marketing authorisation for their products by introducing a new and permanent EU framework for Health Technology Assessment, including through:
- introducing a single EU-level submission file for joint clinical assessments in order to ensure pooling of resources at the EU level and strengthening the scientific quality of HTA across the EU whileavoiding duplication of assessments at national level.
- establishing faster procedures requiring Joint Clinical Assessments to be completed within 30 days after the authorisation of the medicine;
- the systematic consultation of patients and clinicians during the preparation of the assessments as well as the involvement and consultation of the HTA stakeholders.
Starting 12 January, the new rules will apply to marketing authorisation applications for a new cancer medicine or an advanced therapy medicinal product (ATMP).
The rules will be extended to orphan medicines in January 2028 and will as of 2030 cover all new medicinal products.
Selected high-risk medical devices will also be assessed as of 2026.
Questions and Answers: Regulation on Health Technology Assessment
