The regulatory framework for microbiome-based therapies: insights into European regulatory developments.

Julie Rodriguez, Bruno Pot, Céline Druart, Magali Cordaillat-Simmons

Journal: NPJ biofilms and microbiomes 2025;11(1):53

PMID: 40155609

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Abstract

The emergence of a broad spectrum of microbiome-based therapies has triggered changes in European regulatory frameworks. The first part of the review describes these innovative therapies. The second part provides an overview of the current framework and key changes introduced by the Regulation on substances of human origin (SoHO) for the development of microbiome-based therapies, highlighting the need of microbiome regulatory science to unlock the full potential of microbiome-based therapies.

Address: Pharmabiotic Research Institute (PRI), Narbonne, France. [email protected].; Pharmabiotic Research Institute (PRI), Narbonne, France.; Pharmabiotic Research Institute (PRI), Narbonne, France.; Research Group of Industrial Microbiology and Food Biotechnology (IMDO), Faculty of Sciences and Bioengineering Sciences, Vrije Universiteit Brussel, Brussels, Belgium.

DOI: 10.1038/s41522-025-00683-0

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MeSH Terms: Humans, Microbiota, Europe, Probiotics, Fecal Microbiota Transplantation, Biological Therapy