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Fra 1. september 2025 vil Lægemiddelstyrelsen anmode om at modtage bioækvivalensdata i CDISC-format
From September 1, 2025 the Danish Medicines Agency will request submission of bioequivalence data in CDISC format Based on a pilot study conducted by the Danish Medicines Agency during 2023 an
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Combined studies with a clinical trial and a performance study: Sponsors now have the opportunity to apply for approval through a national coordinated application process
The Danish Medicines Agency, in collaboration with Danish Medical Research Ethics Committees, has developed a new guideline on a national coordinated application process for combined studies with a cl