Assessment times for notifications of clinical trial applications in 2011

According to an agreement with the industry, the Danish Medicines Agency must assess applications for authorisation of clinical trials within 30 working days.

The chart shows the assessment times for applications received by the Danish Medicines Agency during each month of 2011.

• Green bars represent applications assessed within the time limit of 30 days. The common European time limit for assessing applications is 60 days, which corresponds to approximately 45 working days.
• Yellow bars, if any, represent applications assessed within 31-45 working days.
• Red bars, if any, represent applications where the maximum of 45 working days has been exceeded.

The assessment time is calculated from the day the Danish Medicines Agency receives a valid application. This date is registered as the “start time” of the application.

On receipt of an application, the Danish Medicines Agency immediately sends an acknowledgement letter to the applicant, advising the applicant whether the initial review of the application has given rise to remarks or whether the application is valid (i.e. complete). The “end date” is the day when the Danish Medicines Agency sends its first reply to the applicant. This is the end date registered for each month in the chart. Hence, an application completed in February has not necessarily been submitted to the Agency in February, but could have been submitted in e.g. December 2010.