Paris, France, June 10, 2025 – On March 18, 2025, the Microbiome Times Forum, co-organized by the Microbiome Times together with EMIH (European Microbiome Innovation for Health) and MTIG (Microbiome Therapeutics Innovation Group), opened its doors to +500 participants including regulators, health technology developers, healthcare professionals, and academic experts involved in the microbiome sector from across the world. This groundbreaking congress is the only one in Europe exploring the industry’s latest trends, scientific advancements, challenges, and opportunities to accelerate the development of microbiome innovation.
This year, experts and participants were gathered in Brussels, a highly symbolic city currently hosting negotiations of key legislative texts to define a regulatory framework for pharmaceuticals, SoHO and biotechnologies. On this note, a unique, cross-expertise panel was held on this topic for the first time, featuring leading voices from the field:
- Christelle Bouygues, Senior Regulatory Affairs Specialist at the European Medicines Agency (EMA);
- Professor Xavier Poiré, Department of Hematology, Cliniques Universitaires Saint-Luc (Belgium);
- Staffan Strömberg, CEO, Infant Bacterial Therapeutics AB;
Moderated by Hervé Affagard, President of the European Microbiome Innovation for Health Association.
The discussion highlighted the need for a dedicated and adapted regulatory framework for emerging therapies based on the microbiome that ensures quality, safety and efficacy. This is most important as the latter strives to treat some of the world’s most vulnerable populations, including premature infants, immunocompromised patients with Graft-versus-Host Disease (GvHD), oncology patients and also antibiotic resistant bacteria, among other diseases.
The upcoming SoHO Regulation, set to apply in 2027 and the new pharmaceutical legislation proposing the introduction of SoHO-derived medicinal products, were mentioned as key legislation to achieve this ambition. As the European Commission and national competent authorities are actively working on the implementation of the SoHO Regulation, panelists emphasized the importance of collaboration to include the perspectives of healthcare professionals, health technology developers and regulators to draft guidelines which are specific to the sector. This could include work on standardization, process definition, and product classification.
The European Medicines Agency (EMA) reiterated its openness to stakeholder engagement and specifically called on microbiome developers to “knock on its door early” to engage early dialogue with regulators and enhance their chances of success on the development and authorisation of their microbiome medicinal products.
What is more, panelists exchanged on the possibility to create a dedicated “microbiome team”, building on the experience of the U.S Food and Drug Administration (FDA) which created the Microbiome Working Group.
Microbiome Times Forum 2025 confirmed that coordinated action among healthcare stakeholders is the key to unlocking the future of microbiome health technologies in Europe. EMIH is willing to collaborate with all European institutions to ensure safe and timely access to promising microbiome innovation and ensure that Europe becomes a global leader in the field.
About European Microbiome Innovation for Health
EMIH is an independent coalition within the European Union, the United Kingdom, and Switzerland, currently comprising 27 major players from the public and private sectors. From the laboratory to the patient’s bedside, EMIH covers the entire value chain of the microbiome industry. Its goal is to position Europe as a global leader in the development, production, and commercialization of microbiome-based therapeutic innovations.
EMIH members include Bioaster, Biocodex, BioGaia, Biofortis, Biose Industrie, Cancer Patients Europe, Enosis Santé, EnteroBiotix, GMT Science, INRAe, Institut Mérieux, IPA Europe, Lallemand Health Solutions, Life Avocats, MaaT Pharma, mbiomics, Microbiotica, Microbiome Foundation, Microviable, MRM Health, Nexbiome, Nextep Health, Novobiome, Pelican Health, PiLeJe, Seventure Partners and SwipeBiome. For more information, please visit www.europeanmicrobiome.org
European Microbiome Innovation for Health Contacts
Memberships: Office@europeanmicrobiome.org
Media Relations: p.richaud@europeanmicrobiome.org
