STATENS LEGEMIDDELVERK

Their core work

The Norwegian Medicines Agency (NoMA) is Norway's national regulatory authority responsible for approving, monitoring, and ensuring the safety of medicines and medical products. In H2020 projects, they contribute regulatory expertise on pharmacovigilance, drug identification standards, and patient safety frameworks. Their participation focuses on harmonizing European drug databases, enabling cross-border eHealth services, and establishing international standards for patient-reported outcomes in clinical settings.

What they specialise in

How they've shifted over time

NoMA's H2020 involvement began in 2017 with broad health policy work (DO-IT on big data for outcomes) and an unrelated botanical taxonomy project (Plant.ID as third party). From 2019 onward, their focus sharpened dramatically toward their regulatory core: medicine identification standards (UNICOM), patient empowerment through medication information (Gravitate-Health), and clinical outcome measurement standards (SISAQOL-IMI). The trajectory shows a clear move from exploratory participation toward deep engagement in EU-wide pharmaceutical data harmonization.

NoMA is increasingly focused on EU-wide harmonization of medicine data standards and patient-facing health information — expect continued involvement in digital health infrastructure and regulatory interoperability projects.

How they like to work

NoMA exclusively participates as a partner rather than leading consortia, which is typical for a national regulatory authority contributing domain expertise rather than driving research agendas. With 157 unique partners across 24 countries, they engage in large-scale European consortia — their projects tend to be multi-country regulatory harmonization efforts requiring broad institutional buy-in. Working with them means accessing a national medicines regulator's perspective, useful for projects needing regulatory validation or policy input.

Extensive European network of 157 partners across 24 countries, built primarily through large regulatory harmonization consortia. Their reach spans most EU/EEA member states, reflecting the pan-European nature of medicines regulation.

What sets them apart

As Norway's national medicines regulator, NoMA brings an authority perspective that most academic or commercial partners cannot — they are both a user and a shaper of the standards being developed. Their involvement signals regulatory relevance and can help projects align outputs with real regulatory requirements. For consortium builders, having a national medicines agency on board adds credibility and ensures practical applicability of project results in the regulatory domain.

Highlights from their portfolio

• UNICOM
  Largest funded project (EUR 637,769) focused on scaling global medicine identification standards (IDMP) — directly tied to NoMA's core regulatory mission.
• Gravitate-Health
  Long-running IMI2 project (2020-2026) on empowering patients with health information, representing NoMA's engagement with patient-facing digital health.
• SISAQOL-IMI
  Establishing international standards for patient-reported outcomes analysis — positions NoMA at the intersection of regulatory science and clinical evidence.