This will be the new evaluation time for phase I and phase I/II studies in Denmark.
This initiative will go live on August 14th at 14:00 CET🤩
We invite you to an extended Open Mic🎤 session where we will answer your questions.
Download the invite here
On August 7th, 2025, we will publish the regulatory guidance that describes the requirements and timelines in detail. The information will become available here.
We proudly launch this accelerated evaluation timeline in collaboration with The Danish Medicines Agency.
This is possible because of the resources made available by The Danish Life Science Strategy 🚀