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 EDQM under the Council of Europe publishes the tissues and cells guide. The 5th edition was published in 2022, available here. The EDQM currently works on the 6th edition, scheduled for publication in 2027, including a revised chapter on intestinal microbiota. In the 6th edition of the guide, specific standard, good practice guidelines, recommendations and supplementary information will be specified, along with monographs of encapsulated and liquid suspension microbiota preparations.

GAPP-PRO: good tissue practice (GTP)

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.
http://goodtissuepractices.eu/ and https://gapp-pro.eu.

The Euro GTP II tool has been developed by the EDQM to facilitate good tissue practices (GTP). As a part of the GAPP-PRO project, supplementary GTP guidance has been published that specifically describes good tissue practices for faecal microbiota and breastmilk. Find the report 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.