The European Directorate for the Quality of Medicines & HealthCare (EDQM), in collaboration with the European Commission (DG SANTE), is co-ordinating a project to define a minimum activity data set for blood and blood components, in line with Article 41 of Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application (SoHO Regulation).

The aim is to establish a standardised dataset that can serve as the foundation for more structured and comparable data collection and reporting on blood and blood components across Europe, supporting donor and recipient protection, monitoring the sufficiency of blood and plasma supply, promoting transparency and oversight of activities and minimising duplication while improving efficiency.

The project is being led by a working group under the European Committee on Blood Transfusion (CD-P-TS), including experts from Council of Europe member states and extended to professional associations in the field. The work is organised in close co-ordination with the SoHO Coordination Board (SCB) implementing the SoHO Regulation.

Stakeholders will also be invited to provide feedback during the consultation phase in 2026.

For more information and project updates, see the EDQM webpage: Activity data set for blood and blood components.

See also:

• EDQM releases new report highlighting key trends in blood collection, supply and use in Europe
• CD-P-TS – Background & mission
• Areas of work – Blood