EU regulation on health technology assessment (HTAR)

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

What is covered by the regulation?

The above date marked the beginning of a legally mandated European cooperation on health technology assessments (relative safety and clinical effectiveness).

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.

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. These assessments are based on a dossier that contains clinical documentation provided by a company to the European HTA Secretariat.

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

In addition to health technology assessments, the regulation establishes a framework and procedures for cooperation within the EEA on joint scientific consultations for health technology developers. These consultations guide companies during the planning of clinical studies, focusing on the evidence needs for a subsequent assessment.

Timeline for introduction

The system for joint clinical assessments will be introduced gradually. Starting in 2025, it will be limited to medicinal products with new active substances for the treatment of cancer and advanced therapies. A selection of medical devices will be assessed from 2026 onwards.

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

In 2030, the cooperation will include joint assessments of all medicinal products with a new active substance pending marketing authorization, as well as selected medical devices and extensions of indications for medicinal products that have previously been assessed.

Find more information on the implementation of Regulation 2021/2282 here.

Implementation in Norway

Regulation 2021/2282 has been incorporated into the EEA Agreement, and therefore, Norway is obliged 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 necessary adaptations of the national system to the regulation. In 2025, these stakeholders will continue to collaborate and adapt Nye Metoder making use of earlier experience.

The HTAR does not affect Norway's authority to interpret health technology assessments nationally or to make decisions regarding use and public funding of health technologies within the country.

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

This page will be continuously updated. The short address for this page is dmp.no/en/htar.