Regulation

EU regulation of SoHO

Substance of human origin
Substance of human origin (SoHO) is a term applied by the European Commission to embrace blood, tissues, cells, organs and human-derived material such as breast milk and intestinal microbiota.

EU regulation of blood, tissues, and cells
The EU legislation on blood, tissues and cells is under revision to include all SoHOs. In July 2022, the European Commission adopted the proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application. Follow the process.

Medicinal products
Medicinal products are regulated by the European Medicines Agency (EMA) according to the appropriate EU regulation. In the regulation proposal issued 26 April 2023 (see the proposal here), SoHO-derived medicinal product are briefly mentioned.