Denmark sets a new EU benchmark for clinical trial timelines
With the Strategy for Life Science towards 2030 (New Danish life science strategy), published in November 2024, the Danish government committed to establishing a fourth Medical Research Ethics Committee. The goal? To ensure Phase 1 trials are processed within just 14 days, reinforcing Denmark’s position as one of the most attractive locations in Europe to conducting clinical trials.
On 14. august 2025, the new 14-day assessment process for phase I trials was officially launched. It includes concurrent regulatory and ethics assessments of applications, a collaboration between the Danish Medicines Agency (DMA) and the Danish Medical Research Ethics Committees (MREC).
Initially, the fast-track timeline will automatically apply to all mono-national phase I and phase I-II trials. For multinational trials, accelerated approval will depend on other Member States matching Denmark’s speed. The DMA and MREC encourage other countries to adapt similar rapid assessment models, improving Europe’s competitiveness as a whole.
“The Danish model proves that regulatory innovation is a competitive edge. Tight timelines reveal systemic strength in the Danish system. Only efficient systems can deliver at speed. Sponsors recognize that rapid timelines mean broader capabilities beyond mere processing speed. By guaranteeing 14-day approvals, we invite sponsors to push other EU countries to match us. It’ll make all of Europe more competitive, not just Denmark.”
“Clinical trials are crucial for the Danish patients and our healthcare system, they bring new knowledge, innovation and treatment options, all to the benefit of the patients. At Invest in Denmark, we actively work to attract more clinical trials to Denmark, and we’re seeing a growing number of the world’s leading life science companies choose Denmark. With the new 14-day assessment time, I am confident this growth will continue.“
