EU regulation: Substance of human origin (SoHO)

Substance of human origin
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

EDQM tissue and cells guide

The Council of Europe issues the technical guide for the safety and quality of tissues and cells for human application. The guide was thoroughly revised in 2022, including the adaptation of a thoroughly revised chapter on intestinal microbiota.
Read the current 5th edition of tissue and cells guide.
The revision of the tissue guide is a dynamic process, and the revision for the coming 6^th edition was initiated in May, 2023. It is expected that the 6^th edition is issued in 2026.

EuroGTP II, good tissue practices

Good tissue practices are key for the quality and safety of substances of human origin. The EuroGPT I and II projects are founded in the EDQM. EuroGTP II is coordinated by the Banc de Sang i Teixits (BST) under the Catalan Department of Health, Catalonia, Spain. The aim is to provide practical tools for quality risk management in SoHO establishments. In November, 2025, the EuroGTP II releases supplementary guidance on the evaluation of new SoHOs, human milk and intestinal microbiota, developed under the GAPP PRO Joint Action.
http://goodtissuepractices.eu/ and https://gapp-pro.eu.

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.