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 and 2024 we have decided that bioequivalence data in CDISC format (Clinical Data Interchange Standards Consortium format) should be used routinely in the assessment of marketing authorisation applications and variations.

For applications submitted from September 1, 2025, including one or more bioequivalence studies, it means that the Danish Medicines Agency will request bioequivalence data to be submitted in CDISC format in all purely national applications and in DCP and MRP procedures with Denmark as Reference Member State (RMS), including variations. This applies regardless of the legal basis.

Please see Application for marketing authorisation for further information.