Assessment times for notifications of clinical trial applications 2020
In the link below is given assessment times up to the first reply regarding applications for clinical trials per month. The average processing time for first reply was 25 days in 2020.
According to an agreement with the industry, the Danish Medicines Agency must submit the first reply to applicants within 42 days. This aim has now been sharpened to 35 days in preparation for the shorter deadlines under the new regulation