The European collaboration on health technology assessments under the HTA (Health Technology Assessment) Regulation is now well underway.
Totally 15 medicines are currently undergoing the same process, and several more assessments are expected to start during 2026. These reports provides a joint European assessment of the medicine’s relative clinical effectiveness and safety.
Encouraging early dialogue with suppliers
Marketing authorisation holders must also request a national health technology assessment for medicines assessed under this framework.
The Norwegian Medical Products Agency (NOMA) has now updated the documentation templates for health technology assessments so that they also apply to medicines covered by the HTA Regulation.
We encourage companies to engage in early dialogue with NOMA about the process for national health technology assessments whenever needed.
There are several different types of health technology assessments, each with distinct documentation requirements.
Updated submission templates
To clarify which parts of the submission dossier are now covered through the European JCA process, NOMA has updated the national documentation templates for submissions.
Updated submission templates are available here
Important information for suppliers:
- NOMA offers early national dialogue meetings with suppliers to clarify the Norwegian PICO and provides pre-submission meetings to guide companies on additional documentation requirements for national assessments.
- The first submissions under the new framework will function as pilot procedures, and processes may be adjusted based on experience gained during implementation.
- Suppliers may submit requests for national health technology assessments before the public release of the JCA report. However, DMP will not initiate formal assessment procedures until the JCA report has been published.