FAST-EU and The Nordic Federated Health Data Network: How the Nordics Are Accelerating Clinical Research in 2026

Entering 2026, new regulatory and data-driven initiatives are beginning to reshape how studies are designed, approved and executed across the Nordic region. This article examines recent developments including the rollout of FAST-EU and the Nordic Federated Health Data Network and explores how these changes are strengthening the Nordics’ position in clinical research, whilst also covering the challenges that remain.

Firstly, the FAST-EU pilot has launched to streamline multinational trial approvals across Europe. Nordic regulators are central to this, though national timelines vary. Denmark set a new benchmark in August 2025, offering a 14-day evaluation for mononational Phase I and II applications - the fastest in Europe. Similarly, Sweden introduced a fast-track in September 2025, targeting 30-day approvals for complete submissions. These reforms reflect a regional commitment to rapid study initiation and reduced administrative friction, positioning the Nordics as an attractive region for early-phase clinical development.

Together, these national reforms reflect a broader Nordic commitment to shorter start‑up times and clearer regulatory expectations, even as full harmonisation across countries remains a work in progress.

The Nordic region’s enduring advantage lies in its real-world data infrastructure, increasingly coordinated through the Nordic Federated Health Data Network. Operating through a federated model, this network enables cross-border analyses while patient-level data remains within national secure environments.

Entering 2026, this approach supports feasibility assessments, cohort identification, and selected post-authorisation studies in line with GDPR requirements. While advanced analytics are developing across the region, they are primarily implemented within national or disease-specific programmes, positioning the federated model as a pragmatic, high-trust framework rather than a fully unified Nordic data platform.

While the Nordic region maintains a strong early-stage drug development pipeline, securing capital for late-stage (Phase III) development remains a significant hurdle. As across much of Europe, limited access to large-scale international financing increases the risk that promising assets are licensed or relocated outside the region before reaching pivotal trials. Policymakers are increasingly focused on attracting global venture capital while seeking to retain scientific leadership locally.

Legal complexities continue to impede the cross-border sharing of raw patient-level data. Despite the region’s digital maturity, differing national interpretations of EU data protection legislation mean that expanding a study from Norway to Denmark, for example, still requires navigating distinct ethical and regulatory frameworks. While initiatives linked to the European Health Data Space aim to improve alignment and enable more efficient data access in the coming years, full interoperability has yet to be realised. As a result, sponsors typically manage Nordic studies as coordinated national efforts rather than as a single, unified data ecosystem.

As 2026 unfolds, the Nordic clinical trials sector stands out for its balance of speed, trust and data depth. Accelerated approval pathways and federated health data collaboration are improving study start-up and evidence generation, even as challenges in funding and legal harmonisation persist. For sponsors, the key will be monitoring how FAST-EU evolves and whether initiatives linked to the Nordic Federated Health Data Network can reduce remaining barriers. Together, these factors will determine how far the Nordics can translate structural strengths into long-term research leadership.

About the Author

Rhys

Rhys Wallett joined The PBC Group in October 2025 as a Conference Producer, where he researches and produces life sciences meetings for clinical-stage biopharma organisations. In his role, Rhys develops targeted conference programs that bring together key stakeholders across the clinical research ecosystem, from CROs and pharmaceutical sponsors to biotech innovators and regulatory experts. His work focuses on identifying emerging trends in clinical development and translating complex industry challenges into actionable conference content that drives meaningful dialogue and collaboration within the life sciences community.