Improved guidance on the definition of a clinical trial of medicinal products

The Danish Medicines Agency acknowledges that it is often difficult to find out whether or not a trial is to be classified as a clinical trial of medicinal products.

We have therefore updated chapter 1 of our Guideline for applications for authorisation of clinical trials of medicinal products in humans and have also included some examples of what is not a clinical trial.

Along with the update, we have published information that can help researchers find out whether a trial is a clinical trial of medicinal products or possibly a non-interventional study.

• Guide to assessing if a trial falls under the definition of a clinical trial