EU Regulation on Health Technology Assessment

HTAR – Health Technology Assessment Regulation (HTAR) 2021/2282 applies throughout the EEA, including Norway, from 12 January 2025.

What is covered by the regulation?

This date marked the beginning of a legally mandated European cooperation on health technology assessments of relative effectiveness and safety. These assessments are based on a dossier containing clinical documentation submitted to the European HTA Secretariat by companies. The HTA Regulation establishes a framework and procedures for cooperation within the EEA on health technology assessments. It sets common rules for collaboration and communication, as well as the use of methods for joint clinical assessments of health technologies.

Read more about the regulation.

The HTA Regulation does not affect national sovereignty over decisions related to pricing and reimbursement or national competencies regarding the management and financing of health services and treatments.

Health technology assessment is defined in the HTA Regulation as a scientific, evidence-based process that allows for the evaluation of the relative effectiveness of new or existing health technologies.

In addition to health technology assessments, the HTA Regulation establishes a framework and procedures for cooperation within the EEA on joint scientific consultations for health technology developers. These consultations enable companies to receive guidance during the planning of their clinical studies, focusing on the evidence needs for a subsequent joint clinical assessment under the HTA Regulation.

Timeline for introduction

The system for joint clinical assessments will be introduced gradually. From 2025, it will be limited to medicinal products with new active substances for the treatment of cancer and advanced therapies (ATMP). A selection of medical devices will be assessed from 2026. From 2030, the cooperation will include joint clinical assessments of all medicinal products with a new active substance for which marketing authorization is sought, as well as selected medical devices. Additionally, it will cover indication extensions for medicinal products that have previously been assessed under the HTA Regulation.

Joint scientific consultations for medicinal products and medical devices will commence in 2025.

Find more information on the implementation of the HTA Regulation at the EU level here.

Implementation of the regulation in Norway

The HTA Regulation has been incorporated into the EEA Agreement, and in this way, Norway is obligated to implement the regulation.

In 2024, a national working group composed of representatives from Nye Metoder Secretariat, the regional health authorities, The Norwegian Radiation and Nuclear Safety Authority, and DMP, as well as patient representatives, has worked on the necessary adaptations of the Nye Metoder system to align with the HTA Regulation. In 2025, the stakeholders will continue their collaboration to further adapt Nye Metoder to the HTA Regulation, among others based on experiences gathered along the way.

The HTA Regulation does not affect Norway's authority to draw its own conclusions in Norwegian health technology assessments or to make decisions regarding national use and public funding of health technologies.

Find updated information on the adaptation of the Nye metoder system here.

This page will be updated with more information throughout 2025. The short address for this page is dmp.no/en/htar.