APPROVAL PROCESS 

 

Denmark has created the fastest and most efficient approval system in Europe for clinical trial authorization:

 

• Handling time for The Danish Medicines Agency is 30 days. Applications can be submitted in English allowing international partners to apply

• The local Ethics Committee meets once every month and applications are submitted in English with a Danish summary

• The regulatory authorities provide fast and efficient guide and support to applications

• Combined protocols including both first-in-man and IB/IIB can be submitted to the authorities