Danish Medicines Agency has assessed and sent out replies for an exceptionally high number of clinical trial applications in March
The Danish Medicines Agency has been extremely busy lately with the assessment of applications for clinical trials – not only COVID-19-related applications, but also applications for clinical trials of other medicines. All applications have been assessed, and all applicants have received a timely reply.
In March, the Danish Medicines Agency received 41 clinical trial applications – 14 of which were related to COVID-19. This is almost twice as many as the Danish Medicines Agency usually receives compared to the monthly average over a year.
All applications were responded to within the time limit
Just two weeks ago, the Danish Medicines Agency introduced an accelerated procedure for the assessment and approval of clinical trials of medicines for treatment of COVID-19. This was done to support the fast development and approval of effective and safe treatments and vaccines for COVID-19. The accelerated procedure means that all applications for COVID-19-related clinical trials are processed within approximately three days.
Other clinical trial applications are reviewed within 35 days – the new time limit for 2020, which was shortened from the previous 42 days.
All applications processed in March have been assessed and initially responded to within the time limits of 3 or 35 days, respectively.