Inspection of clinical trials (GCP inspection)

 Inspection by the Danish Medicines Agency

The primary purpose of clinical trial inspection is to ensure that trials are conducted in accordance with the authorisation granted, the trial protocol approved, applicable law and good clinical practice (GCP). GCP is a set of international, recognised ethical and scientific standards that are applied in the design, conduct and reporting of clinical trials of medicinal products in humans.
 GCP compliance is to ensure that the rights, safety and well-being of trial participants are protected, and that the results of the clinical trial are reliable.

The Danish Medicines Agency has statutory authority* to inspect any company etc. that carries out or has carried out clinical trials of medicinal products in Denmark. 
*EU Regulation No 536/2014 (section 52) (the Regulation) and section 19 of the Danish Act on Clinical Trials of Medicinal Products. 

The Danish Medicines Agency inspects clinical trials of medicinal products both in Denmark and abroad. This includes inspections coordinated by the European Medicines Agency (EMA).

When the Danish Medicines Agency conducts national inspections, it follows its own procedures. These procedures describe how trials are selected for inspection, the notice, conduct and reporting of inspections and the follow-up on observed deviations.

When the Danish Medicines Agency conducts inspections on behalf of the EMA, it follows the procedures published by EMA. 
The main difference between national inspections and inspections conducted on behalf of the EMA is that EMA inspections are conducted as part of the application process for a marketing authorisation whereas this is typically not the case for national inspections. 

EXECUTIVE ORDER
Bekendtgørelse af lov om kliniske forsøg med lægemidler §19
REGULATION
Regulation - 536/2014  (section 52)
GUIDELINE
Procedures published by the EMA


Change log:
20 April 2026 –No substantive changes