EU SoHO Regulation

Substance of human origin (SoHO)
Substance of human origin (SoHO) is a term applied by the European Commission to embrace blood, tissues, cells and human-derived material such as human milk and intestinal microbiota. The process to develop the recently adopted SoHO Regulation is described here.

EU SoHO Regulation
The EU SoHO Regulation was published 17 July 2024 and will be implemented in all EU member states over the next three years. The regulation – Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (Text with EEA relevance) – is published here.

Medicinal products
In the EU, 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. The main documents for the reform of the EU pharmaceutical legislation are published here. The timeline is published here.

Revision date: 27.1.2025