Background & National Role
Why Norway needed a coordinated ATMP framework
Cell and gene therapies hold the potential to cure diseases that currently lack effective treatments. However, translating these therapies from discovery to clinical use involves high technical and regulatory complexity, significant costs, and reimbursement challenges that can delay or prevent patients from accessing innovation.
A national gap analysis conducted in 2023 revealed that Norway lacked the infrastructure, strategy, and capabilities needed to develop and deliver advanced therapies at a national level.
Identified national gaps
Unequal access to innovation across the country.
Limited pre-GMP capacity outside Oslo.
No coordinated national ATMP strategy.
No national GMP-grade quality control service.
Delayed translation, higher costs, and weaker national preparedness.
Founded in 2025 as a joint initiative of Oslo University Hospital and Haukeland University Hospital, ATMP Norway operates as a multi-nodal national infrastructure spanning Oslo and Bergen.
It aligns infrastructure, expertise, governance, and public-private collaboration across the full development value chain — from discovery and pre-GMP process development through GMP manufacturing, quality control, training, and regulatory support, all the way to patient access.
50 M NOK
Funded by the Research Council of Norway · FORINFRA programme · Project 350614 · Started October 2025