Austin, TX, 27 October 2025 – The Danish Medicines Agency (DKMA) previously announced that, effective 1 September 2025, data submitted for the assessment of marketing authorization applications and variations must be provided in CDISC format. This includes applications containing bioequivalence data, which will need to follow CDISC Standards.
The requirement applies to:
- All purely national applications
- Decentralised Procedure (DCP) and Mutual Recognition Procedure (MRP) submissions with Denmark as the Reference Member State (RMS), including variations
- Applications regardless of legal basis
Submissions must follow DKMA specifications, including:
- File formats: SAS Transport Format (XPORT) Version 5, PDF, XML
- Data standards: CDISC SDTM 1.2 or higher; ADaM + programming statements for dataset creation and analysis output (optional), including SDTMIG and define.xml
This decision represents an important step in harmonizing regulatory data requirements globally. The U.S. Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) already require CDISC standards for clinical and nonclinical study data. The European Medicines Agency (EMA) encourages their use, and the National Medical Products Administration (NMPA) in China has also advanced CDISC implementation.
“Requiring CDISC standards for marketing authorization assessments, including bioequivalence studies, is a critical step toward greater regulatory harmonization across the globe,” said CDISC President and CEO, Chris Decker. “This decision reflects a growing global consensus that standardized data improves quality, streamlines regulatory review, and ultimately helps patients by accelerating access to safe and effective medicines.”
For further information, please see the DKMA guidance: Application for marketing authorisation.
About CDISC
Clinical Data Interchange Standards Consortium (CDISC) creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the European Medicines Agency (EMA) and China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)3 global nonprofit charitable organization with thousands of partners, volunteers, and member organizations around the world.
