The Danish Medicines Agency requires bioequivalence data in a better data format
In future, the Danish Medicines Agency will request that data from bioequivalence studies be submitted in an additional data format to that used today. Businesses applying for approval of new medicines or submitting variation applications will be required to submit data in CDISC format from 1 September 2025.
In 2023 and 2024, the Danish Medicines Agency conducted a pilot study to look into how bioequivalence data in CDISC format (Clinical Data Interchange Standards Consortium format) may be used in connection with the Agency's assessment of the bioequivalence studies submitted when a pharmaceutical company applies for approval of a new medicinal product.
Generic manufacturers in particular use bioequivalence studies as approval of a generic drug will only be granted f the manufacturer documents that, in the body, the generic drug behaves identically to that of the original drug. In other words, it must be bioequivalent, and this can be demonstrated through bioequivalence studies.
The pilot study findings led to the Danish Medicines Agency's decision that clinical data from bioequivalence trials in CDISC format should in future be included routinely when the Agency assesses marketing authorisation and variation applications. Among other things, the CDISC format helps qualify the questions asked by the Danish Medicines Agency to the application, while making it easier to access data and improve the possibilities of analysis.
“The pilot project has shown us that our assessment basis improves when clinical data are submitted in the CDISC format, and thus it also reduces the burden on applicants. "Going forward, we therefore request that data be sent in this format for our Danish applications for approval," says Hanne Lomholt Larsen, Director of Division.
The change applies to all national applications as well as applications where Denmark is the reference member state (RMS) for the decentralised procedure (DCP) or the mutual recognition procedure (MRP).