SoHO Regulation Text

Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application (SoHO Regulation)

Adopted in June 2024, the SoHO Regulation aims to improve the safety and quality of all substances of human origin for human application, including blood, tissues and cells. It covers a wide range of activities from the registration and testing of donors, collection and processing, to human application and clinical outcome monitoring of SoHO. The Regulation seeks to strengthen the existing legal framework while also becoming more future-proof to more easily accompany new scientific evidence and innovation in the field.

The new Regulation will apply as from 7 August 2027, 3 years after its publication and entry into force, with an extra year for certain provisions. Until then, the current Blood and Tissues and Cells EU Directives, and the national legislation that transpose them into national law, remains applicable.

You can read here EBA’s statement to the adoption of the SoHO Regulation.
Download the English version below or view the Regulation is available in all EU languages.