Biofortis announces that it has obtained authorization from the French National Agency for the Safety of Medicines and Health Products (ANSM) for its activities involving the collection of human stool samples intended for the preparation of fecal microbiota for therapeutic purposes.
Effective as of March 27, 2026, this authorization was granted in accordance with the provisions of Decree No. 2023-672 of July 27, 2023, relating to the authorization of stool collection activities and the importation of stool samples or fecal microbiota preparations.
For the past fifteen years, Biofortis has invested in the study and, more recently, the collection of microbiota for therapeutic purposes. This authorization marks a key milestone for Biofortis and forms part of a European drive to ensure the quality and safety of substances of human origin (SoHO – Substances of Human Origin) intended for human application.
Thanks to this authorization, Biofortis is now able to support stakeholders in the field of fecal microbiota, biotech companies, pharmaceutical laboratories, developers of probiotics and new strains, in the development of innovative therapeutic projects, within an environment compliant with European SoHO requirements.
This achievement positions Biofortis among the first players in France capable of mastering the entire fecal microbiota value chain. It covers the selection of healthy donors, the collection and management of pharmaceutical raw material, while preserving the functional diversity of the microbiota and ensuring the safety of treated patients.
“Over the past eight years, we have delivered more than 700 kg of fecal microbiota for pharmaceutical use with one absolute priority: ensuring product safety and patient access to treatments. This authorization, granted within a stable regulatory framework aligned with the European SoHO regulation and established by the ANSM, marks an important milestone for our sector. It simplifies access to the collection of stool samples for therapeutic purposes and confirms the quality of the work carried out by our teams. It also contributes to structuring an industrial approach that is essential to the success of innovative therapies based on complete microbial ecosystems. In many cases, these therapies remain the only effective option available, particularly in the management of complex diseases.”
– Benoît Fouchaq, President of Biofortis Group