EMIH member Mikrobiomik has announced that EUTEGRA® (MBK-01), its microbiota-based therapy for recurrent Clostridioides difficile infection (CDI), has been authorized in Spain under the National Spanish Substances of Human Origin (SoHO) framework (the SoHO Regulation was published in July 2024 and will apply from 7 August 2027 following a transition period)1.
The authorization has been processed through the Basque Country’s Regional Transplant Coordination and has undergone technical evaluation by the National Spanish Transplant Organization (ONT) and the Spanish SoHO Innovation Evaluation Committee (CEI-SoHO), established by the Spanish Transplant Commission of the Interterritorial Council of the National Health System and coordinated by the ONT.
Mikrobiomik has initiated discussions with the Autonomous Communities for the provision of EUTEGRA (MBK-01) in Spain and to enable access to this therapy in hospitals across the country.
This milestone represents an important development for both Mikrobiomik and the broader microbiome sector, illustrating how emerging SoHO-based regulatory pathways can support access to innovative solutions while ensuring standards of quality, safety and traceability.
Following this major step, Mikrobiomik is working towards broader access to EUTEGRA® within Spain and evaluating potential future expansion into other European markets.
What is SoHO?
The EU Substances of Human Origin (SoHO) Regulation establishes a harmonized framework for substances of human origin intended for human application, including blood, tissues, cells, human milk, microbiota and other SoHO-derived preparations. Its objective is to strengthen quality, safety and traceability standards while supporting innovation and improving patient access across Europe.
While the EU SoHO Regulation entered into force in 2024, its implementation is expected to become fully applicable starting in 2027, following the transition period established by the Regulation.
When SoHO, other than tissues and cells, are subject to an industrial process involving systematization, reproducibility and operations performed on a routine basis or batch-wise resulting in a product of standardized consistency they become SoHO derived medicinal products and are regulated by the Pharmaceutical Regulation.
For EMIH members and stakeholders active in microbiome and other SoHO-based preparations, this development provides an interesting example of how the evolving regulatory framework may support innovation and patient access across Europe.
Sources & References:
1European Commission, New EU Rules on Substances of Human Origin (SoHO). The Commission notes that the SoHO Regulation was published in July 2024 and will apply from 7 August 2027 following a transition period. https://health.ec.europa.eu/blood-tissues-cells-and-organs/soho-regulation_en
Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
Mikrobiomik press release, February 2026
Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application (SoHO Regulation).
