From 3–5 February, the Pharmabiotics Conference in Brussels brought together scientists, industry and regulators to discuss how microbiome innovation and regulation evolve together. For us, this conference is not just about staying informed. We actively contribute to shaping the regulatory context in which (y)our formulations reach the market.
Where science meets regulation
The Pharmabiotics Conference is organised by the Pharmabiotic Research Institute (PRI), a non‑profit organisation dedicated to microbiome regulatory science. In Europe, PRI plays a recognised role in facilitating dialogue between scientists and authorities, ensuring that microbiome‑specific challenges are properly understood early on.
We are actively part of this dialogue. Eleni Tsompanidou, Head of MD&D at Winclove Probiotics, currently serves as President of PRI, keeping us closely involved in discussions with regulators at both EU and national level. Our own Hannah Egberts, Regulatory Affairs Officer, also attended the conference, contributing to these important discussions.
As Eleni explained in her opening speech at the conference:
“The Pharmabiotics Conference is unique because it brings scientific innovation and regulatory reality together. The microbiome does not belong to a single discipline and neither do the regulatory questions that come with it.”
One health: broader applications, shared regulatory questions
A key theme this year is the One Health approach, reflecting how microbiome applications increasingly span human, animal, plant and environmental health. From microbiome-based biomarkers in oncology and chronic disease, to vaginal microbiome diagnostics for women’s health, to plant and soil microbiomes in agri-food systems. This perspective aligns closely with our ambition to create tangible, positive impact; not only on human health, but also on the health of our planet. At the same time, it highlights that regulatory questions are becoming more interconnected across sectors.
The regulatory landscape continues to take shape
Concretely, several major EU developments were discussed, including: the new Substances of Human Origin (SoHO) Regulation, the EU Biotech Act and evolving guidance from the European Food Safety Authority (EFSA), European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM).
Looking ahead
The Pharmabiotics Conference underlines that science, product positioning, and regulation are increasingly intertwined. It also confirms how fast the microbiome field is moving, and how important it is to stay engaged while regulatory interpretations are still forming. Our role is to be actively involved, understand where regulation is heading, and apply that insight directly into the probiotic formulations we develop for you.
