Increase in clinical trial applications
An increasing number of clinical trial applications, improved production and assessment performance, but also longer assessment times.
In the first half of 2015, the Danish Health and Medicines Authority received 178 clinical trial applications. This is an increase of 20% (37 trials) compared to 2014. In this period, we reviewed 146 clinical trial applications, which is 8% (12 trials) more than in 2014.
Even though production and performance improved, assessment times increased somewhat. We sent a first reply to 82% of the applicants within 42 days, and the average assessment time is 36 days, which meets the requirement of a maximum assessment time of 42 calendar days.