Expedited processing for Phase I and integrated Phase I–II trial applications

14 days

This will be the new asessment time for fase I & fase I/II studies in Denmark.

This initiative went live on August 14.

On August 7, 2025, we have published the regulatory guidance that describes the requirements and timelines in detail.

We are very proud to launch this accelerated assessment as a collaboration between the DKMA / MREC. 

This is made possible due to the ressources provided by the Government´s Life Science Strategy.