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The Danish Medicines Agency will mandate the submission of bioequivalence data in CDISC format for marketing authorization applications starting September 1, 2025.

Key points:

  • Applies to national cases and DCP/MRP cases with Denmark as the RMS.
  • Based on a 2023–2024 pilot study.
  • Transition period outlined to help companies comply.
  • Contact information provided for inquiries.
  • Pharmaceutical companies must ensure compliance to avoid delays in authorization processes.

Region: European Union
Source: https://laegemiddelstyrelsen.dk/da/nyheder/?facets=&tab_p=1

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