The Danish Health and Medicines Authority has looked into the possibility of assessing clinical trials of already marketed medicinal products based on risk adaptation.
We now offer shorter assessment times for clinical trials where the risk involved for patients is not higher than the risk of exposing the trial participant to standard treatment.
These trials are termed Type A trials.
The Danish Health and Medicines Authority offers an assessment time of 14 working days for Type A trials provided that the application is complete when we receive it.
We have designed a form for Type A trials, which can be used as a cover letter. The form may also be helpful in determining quickly if a trial falls under the risk-adapted assessment.
We have also prepared a checklist specifically for Type A trials.
You can read more about the criteria to be met if a trial is to be assessed under the risk-adapted approach in our Guidelines on application for authorisation of Type A trials
