Approval Process

The application and processing procedure for conducting clinical trials in Denmark is very simple. Comparison of clinical trials’ approval processes in selected European countries show that the processes in place in Denmark are among the most efficient.

The fast and efficient approval system is characterized by:

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

  • Local Ethics Committee to meet once every month. Applications can be submitted in English with a Danish summary.

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

  • Combined protocol including both first-in-man and Ib/IIa can be submitted to the authorities.

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