The Danish Medicines Agency's guideline on extraordinary measures for clinical trials due to COVID-19 will not be extended after 01 December 2021

04 November 2021

The Danish Medicines Agency's guideline on extraordinary measures for clinical trials due to COVID-19 will not be extended after 01 December 2021

We have chosen not to extend the validity of our guidance on extraordinary measures for clinical trials due to COVID-19 further, why the guidance and the granted exemptions expire on 01 December 2021.

The Danish Medicines Agency do not require any notification on changes caused by the COVID-19 restrictions

Our COVID-19 guidance has required ongoing submissions of deviations caused by the COVID-19 pandemic. These notifications have not given rise to any action from our part. Therefore, we find it sufficient as the guideline is cancelled that no further notifications are submitted to us. All deviations must be documented and we point out that this will be a focus area for future GCP inspections. This is also reflected in our newest version of our COVID-19 guidance.

The Danish Medicines Agency have gotten important learnings from the COVID-19 pandemic

Decentralised elements as implemented under COVID-19 have proven successful and to the benefit of the trial participants. The Danish Medicines Agency therefore focuses on developing the regulatory framework for decentralisation of clinical trials in both Denmark and the EU. You can read more about this initiative on our website and in our new guide on decentralised clinical trials.

 

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