WG C : leading efforts to advance regulatory science and establish guidelines for microbiome products

Working Group C (WG C) on Microbiome Product Development and Regulatory Science is bringing together global experts to tackle the evolving regulatory landscape for microbiome products. Led by Chrysi Sergaki (MHRA), Kristin Wannerberger (Ferring Pharm.), Karine Clement (Inserm/Sorbonne Université/APHP), and Hervé Affagard (Maat Pharma), the group will address eight key areas, including safety, quality, clinical trials, pharmacomicrobiomics, health claims, and the regulation of both medicinal and non-medicinal microbiome products.

Advancing Regulatory Science for Microbiome Innovation

While microbiome science is advancing, there is still a lot to be done to support and establish relevant regulatory guidelines and procedures. Working Group C aims to bridge the gap of accelerating innovation and addressing regulatory challenges by fostering scientific consensus and developing evidence-based guidance that could strengthen confidence among regulators, innovators, academy and investors.

The group will hold a series of virtual expert-led thematic workshops in 2025–2026, each of such group producing white papers on key regulatory challenges. Eight selected items are :

1. Pharmacokinetics-pharmacodynamic (PK–PD), potency, toxicity, and dosing;

2. Safety of medicinal and non-medicinal products;

3. Quality and consistency standards;

4. Clinical trial design and biomarkers;

5. Health claims for non-medicinal products;

6. Microbiome diagnostics;

7. Pharmacomicrobiomics;

8. Regulation of non-human microbiome products.

Organisation of thematic workshops

The co-chairs of the working group C foresee three half-day fully online working sessions open to participants from all relevant sectors. Most of the content being produced during the meetings, the experts would not require additional time to work on the content. Their contributions will be collected by dedicated task leaders, who will coordinate outputs and propose a draft of the white papers.

The group’s chairs hope to ensure inclusivity, balanced representation, and objectivity, with a focus on building shared understanding rather than prescriptive rules.
“Regulatory science must evolve in step with innovation,” says co-chair Chrysi Sergaki (MHRA), highlighting the importance of consensus in fostering public trust.

The outcomes of Working Group C will feed into WMP’s broader mission to harmonize standards and integrate microbiome science within the One Health framework globally.

Experts interested in joining the workshops are invited to register.