Regulation on Standards of Quality and Safety for Substances of Human Origin (SoHO)
The SoHO Regulation — Regulation (EU) 2024/1938 of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application. It repeals and replaces the Blood Directive (2002/98/EC) and the Tissues and Cells Directive (2004/23/EC) with a single, directly applicable framework covering all SoHO except organs — blood, tissues, cells, breast milk, microbiota and more — and applies from 7 August 2027.
What this does not cover
stated in the document's own scope- Covers substances of human origin intended for human application except organs for transplantation, which remain under the organs directive.
- Governs donation through human application; once SoHO become starting materials for manufactured medicinal products or ATMPs, pharmaceutical legislation applies to the manufactured product.
- An EU framework: US blood and tissue activities run under the FDA regulations (Parts 606/610/630/640 and 1271), a separate system.
- Applies from 7 August 2027 — until then the Blood and Tissues & Cells Directives' national implementations remain the operative law.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
Regulation (EU) 2024/1938 — the SoHO Regulation — is the EU's unified framework for substances of human origin intended for human application: blood and blood components, tissues and cells, and newly captured substances such as breast milk and intestinal microbiota, covering everything except organs for transplantation. It replaces the two-directive architecture that governed the field for twenty years, repealing the Blood Directive (2002/98/EC) and the Tissues and Cells Directive (2004/23/EC). The regulation registers SoHO entities, authorises SoHO establishments and SoHO preparations, sets donor-protection and eligibility standards on the principle of voluntary unpaid donation, imposes quality and safety requirements from collection through distribution, and builds an EU-level structure — the SoHO Coordination Board and the EU SoHO Platform — over the national competent authorities.
Scope & applicability
SoHO entities across the EU: establishments collecting, processing, storing, distributing, or applying substances of human origin to humans, and the donors and recipients they serve. Organs for transplantation remain under their own directive; manufactured ATMPs and medicinal products fall to pharmaceutical law once SoHO become starting materials.
Legal basis & how it acquires force
A regulation of the European Parliament and of the Council of 13 June 2024, published in the Official Journal on 17 July 2024 and in force since August 2024. As a regulation it applies directly in all Member States, ending the divergence the directives allowed. It applies from 7 August 2027, with the SoHO Coordination Board provisions applying from 7 August 2024 and certain transitional provisions running to 7 August 2028; Directives 2002/98/EC and 2004/23/EC are repealed as it takes effect.
Document structure
| Part | Covers |
|---|---|
| Scope, definitions and general principles | The substances covered (all SoHO except organs), the actors, and the principle of voluntary unpaid donation |
| Competent authorities and supervisory activities | National authorities, registration of SoHO entities, and authorisation of SoHO establishments and preparations |
| Obligations on SoHO entities | Quality and safety standards across collection, testing, processing, storage, release, and distribution |
| Donor and recipient protection | Donor eligibility, health protection, and standards protecting recipients and offspring from medically assisted reproduction |
| Vigilance and traceability | Reporting and management of serious adverse reactions and events, and traceability from donor to recipient |
| EU-level structures and final provisions | The SoHO Coordination Board, the EU SoHO Platform, transitional arrangements, and the repeal of the 2002/98 and 2004/23 Directives |
Key requirements
- Registration of SoHO entities and authorisation of SoHO establishments and preparations
- Donor protection and eligibility standards, including voluntary unpaid donation principles
- Quality and safety standards across collection, testing, processing, storage, release, and distribution
- Vigilance: reporting and management of serious adverse reactions and events
- National competent authorities coordinated through the SoHO Coordination Board and the EU SoHO Platform
Implementation tips
- Blood establishments and tissue banks should gap-assess against the regulation now rather than porting directive-era compliance — the entity/establishment/preparation authorisation model and the expanded scope (e.g. breast milk, microbiota) are structural changes, not renamings
Revision notes
Adopted 13 June 2024, published in the Official Journal on 17 July 2024, in force August 2024. It applies from 7 August 2027 (SoHO Coordination Board provisions from 7 August 2024, certain transitional provisions to 2028), repealing Directives 2002/98/EC and 2004/23/EC.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
The regulation consolidates and extends the EU acquis the directives created, and it deliberately borders the pharmaceutical framework: when SoHO are industrially processed into medicinal products or ATMPs, pharmaceutical law takes over, with SoHO rules governing donation, collection, and testing of the starting material. Its US counterparts are the FDA blood framework (21 CFR Parts 606, 610, 630, 640) and the HCT/P regime of 21 CFR Part 1271, which regulate the same activities through establishment registration and CGMP/CGTP rules.
Reg. (EU) 2024/1938: frequently asked questions
Quick answers to common questions about Reg. (EU) 2024/1938.
What does the SoHO Regulation replace?
It repeals the Blood Directive (2002/98/EC) and the Tissues and Cells Directive (2004/23/EC), replacing both — and the divergent national implementations beneath them — with one directly applicable regulation covering all substances of human origin except organs.
When does the SoHO Regulation apply?
From 7 August 2027. It entered into force in August 2024, the provisions establishing the SoHO Coordination Board applied from 7 August 2024, and certain transitional provisions run until 7 August 2028.
What is newly covered compared with the directives?
The regulation's scope is defined by the substance being of human origin and intended for human application, so it captures substances the directives never addressed — breast milk and intestinal microbiota among them — alongside blood, blood components, tissues, and cells.
How does the SoHO Regulation relate to ATMP manufacture?
It governs the SoHO chain — donation, collection, testing, and the activities of SoHO entities. When cells or tissues become starting materials for advanced therapy medicinal products or other manufactured medicines, the pharmaceutical framework (including GMP) governs the manufacturing, while SoHO rules continue to govern the upstream donation and procurement.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.