Danish Medicines Agency shortens the review time for applications for COVID-19 medicine trials

Drug regulatory authorities around the world are taking several steps to speed up the development and availability of medicines to treat and prevent novel COVID-19. The Danish Medicines Agency in Denmark has just implemented an emergency procedure for applications for clinical trials with human subjects.

No medicine or vaccine has yet been developed for COVID-19. Drug regulatory authorities all over the world are therefore supporting researchers and companies in the fast development of medicines and vaccines for COVID-19, for example by processing approvals as fast as possible without compromising on safety.

Most recently, the Danish Medicines Agency reduced the review time for all applications related to tests on human subjects (clinical trials) for medicines for the treatment of COVID-19.

The review time is reduced to about 3 days, provided that not too many applications are submitted at the same time. Normally, the assessment time is 35 days.

Clinical trials

Clinical trials are undertaken to find out how a particular medicine works, what side effects it causes and how it is metabolised in the body.

In Denmark, clinical trials must be notified to the Danish Medicines Agency, which assesses both the quality of the investigation and the patient safety of the trial.

Read more: 16 March 2020 The government to grant fast funding for corona-related research (in Danish only) (Ministry of Higher Education and Science)

Read more: Danish Medicines Agency’s COVID-19 theme.

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