The new SoHO regulation requires higher quality and safety standards within EU
The new SoHO regulation takes effect on August 7, 2027. It demands higher quality and safety standards for substances of human origin intended for use in humans. These include human blood, cells, and tissues, as well as substances such as human milk and gut microbiota.
Affected are blood donation centers, tissue banks, fertility clinics, as well as developers and manufacturers of advanced therapy medicinal products (ATMPs) like cell and gene therapies (CGT).
SoHO-regulation: You should check that now!
Which areas are affected? What measures need to be taken? How can the regulation be integrated into the quality management system in suitable time?
You should clarify all these questions early to plan the necessary steps for compliance with the regulation in good time!
But in addition to routine operations, it is not easy to familiarize yourself with the requirements of the new regulation right in time
Consulting on SoHO regulation
Valicare’ s GMP consultants support manufacturers and users of SoHOs in complying with regulatory requirements up to the implementation of the SoHO regulation into the quality management system. We prepare the necessary standard operating procedures (SOPs) and train your employees accordingly.
We advise you on the delimitation of responsibility toward SoHO facilities and SoHO operating sites and conduct necessary supplier qualifications regarding the release of SoHO preparations, on your behalf.
Your benefits
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Our GMP consultants are specialists for the production and release requirements of pharmaceuticals, ATMPs and blood products.
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With over 300 GMP projects done worldwide each year, we have a proven record in the review, development, and implementation of pharmaceutical quality management systems.
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Long-term experience in conducting GMP audits & gap analyses for manufacturers, facilities and suppliers of human source materials means auditors who exactly know what to do.
Key facts about the new SoHO regulation
Which substances and areas are affected by the SoHO regulation?
Regulation (EU) 2024/1938 establishes a uniform framework for substances of human origin (SoHO) – from blood, tissues and cells to human milk and intestinal microbiota. It replaces Directives 2002/98/EG and 2004/23/EG and significantly extends the scope.
Who is affected by the new SoHO regulation?
The regulation is particularly relevant for contract manufacturers, blood, plasma, and tissue establishments as well as ATMP manufacturers working with human starting materials.
Do you need to register as a SoHO facility or permanent establishment?
If your organization carries out at least one SoHO activity (Article 2, paragraph 1 (c)), at least one registration as a SoHO entity will be required. If processing, storage, release or import/export are also carried out, a permit as a SoHO permanent establishment may also be necessary.
What measures do I need to take under the new SoHO regulation?
New regulatory interfaces, documents, and responsibilities such as person responsible, release responsible, and physician must be designated and anchored in the quality management system (QMS).
When does the SoHO regulation apply – and do I have to act now?
The SoHO Regulation (EU) 2024/1938 enters into force in its national version on 07.08.2027. Transitional provisions apply to existing institutions. We recommend an early readiness check and subsequent integration into the quality management system, QMS, and employee training.
As a GMP service provider, can Valicare support the SoHO implementation?
Yes! We translate the new regulation into practical solutions. With a compact readiness check (GAP analysis) we classify your SoHO activities (registration vs. permission, roles, reporting, and release obligations) and accompany you during the implementation.
We support you in preparing the application documents, implementing the required roles and SOPs into your quality management system and making both your documentation and your team fit with targeted inspection training.
Valicare enables you to act quickly: readiness check, registration/permission, QMS integration, roles & SOPs, training, and inspection preparation – efficient, audit-proof, and practical.
Our GMP Lead Consultants are your point of contact for consulting and implementing a suitable SoHO strategy.
SoHO Webinar on September 3 and 17, 2026 (online)
Get an initial overview of the requirements and the appropriate implementation strategy in our SoHO webinar on the topic: “What’s New in the SoHO Regulation (EU) 2024/1938 — What Manufacturers and Users of Substances of Human Origin Need to Know Now.”
