March 2023: Denmark Regulatory Update

On March 02, 2023, the Danish Medicines Agency published the following update in the News section of its website.

Based on the Professional Forum conducted by the Danish Medicines Agency (DMA) and the Danish Centre for Ethics on January 31st, 2023, the DMA has updated its guidelines on the application and conduct of clinical drug trials under the EU Regulation and has included a trial protocol structure template.

With this update, the Danish Medicines Agency aims to provide a condensed overview of the different guidelines and training programs issued by the European Medicines Agency (EMA) and the legislation related to the EU regulation, as well as a question/answer section to supplement the existing guidelines.

The trial protocol template outlines the necessary information to meet the EU regulation and ICH-GCP requirements for a protocol.

More information can be found here.