Substances of Human Origin: Paul-Ehrlich-Institut to Assume Central Roles Within the Framework of the SoHO Regulation

Substances of Human Origin: Paul-Ehrlich-Institut to Assume Central Roles Within the Framework of the SoHO Regulation

Source: Paul-Ehrlich-Institut

In a recent article in the journal Transfusion Medicine, the Paul-Ehrlich-Institut and the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) gave a clear overview of the most important new structures and requirements. Key aspects are summarised below.

SoHO Regulation: New EU Standards for Quality, Safety and Traceability

The SoHO Regulation, adopted on 13 June 2024, sets new standards for all EU Member States in the regulation of substances of human origin (SoHO) intended for application in humans. It commits all actors to the highest standards of quality, safety and traceability and serves EU-wide harmonisation.

Extended Scope: Which Substances Are Covered

The SoHO Regulation represents a comprehensive set of rules that result in new structures and requirements - both for the authorities and for the affected institutions that carry out activities involving SoHO. The aim of the regulation is to harmonise requirements, protect SoHO donors and recipients, and facilitate the exchange of SoHO preparations between EU Member States. It replaces the previous EU guidelines for blood, tissue, and cells (including reproductive cells) and extends the scope to preparations such as human breast milk or intestinal microbiota. This new scope covers all materials removed from the human body, regardless of whether they contain cells or not, or whether they are live or inactive. These materials include:

• blood and blood components,
• tissues and cells (including reproductive cells and reproductive tissue),
• stem cell preparations,
• other substances of human origin, such as human breast milk and intestinal microbiota and
• blood preparations not used for transfusions, such as serum eye drops.

New Structures: SoHO National Authority, SoHO Competent Authorities, SoHO Coordination Board (SCB) and SoHO Platform

New structures were created with the SoHO regulation. An authority in each EU Member State is designated as the SoHO national authority, which assumes special central tasks such as coordinating communication with the EU Commission, the SoHO national authorities of the other EU Member States, and the other SoHO competent authorities. In coordination with the BMG, the Paul-Ehrlich-Institut is expected to become the SoHO national authority in Germany. There will also be several SoHO competent authorities in Germany. Federal state authorities will probably be responsible for monitoring SoHO, while the Paul-Ehrlich-Institut will probably be responsible for the authorisation of SoHO preparations.

The SoHO coordination board (SCB) was established as the central EU body. The SCB is supported by six topic-specific working groups - the working groups on authorisation, registration, traceability, supply, inspections, and regulatory questions. A digital EU platform called the SoHO platform is currently being established by the EU Commission for cooperation, coordination, and data exchange between the member states and the relevant actors, as well as for public information.

SoHO Authorisation and Application: EU-Wide Marketability of SoHO Preparations

Uniform, high standards for quality and safety will be applied within the EU to SoHO preparations as well as to SoHO donors, recipients, and offspring from medically assisted reproduction (MAR). In the future, SoHO preparations will require authorisation from the SoHO competent authority of the Member State in which the SoHO entity is based. This authorisation will then be valid across the EU. SoHO preparations are thus marketable in all EU Member States, which enables cross-border exchange. Depending on the level of risk associated with using the SoHO preparation, clinical studies may be required as part of the authorisation procedure.

Further Information

Schilling-Leiß D, Hahnloser J, Nowak D, Doll M (2026): SoHO-Verordnung - ein neuer EU-Rechtsakt und seine Auswirkungen.
Transfusionsmedizin 16: 47-57.
Online-Abstract

Klotz D, Hahnloser J, Schilling-Leiß D, Doll M, Berns M (2026): Vom Lebensmittel zur Substanz menschlichen Ursprungs - DieVerordnung (EU) 2024/1938 und ihre Auswirkungen auf den Umgang mit humaner Milch.
Z Geburtshilfe Neonatol Apr 28 [Epub ahead of print].
Online-Abstract

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