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The Medicines and Healthcare products Regulatory Agency (MHRA) has published a position paper on microbiome-based medicines to encourage manufacturers to develop products for the UK market.
Microbiome-based medicinal products (MBMPs) — which contain microorganisms as the active products — treat disease by modulating, restoring or replacing the human biome. There are currently no UK marketing authorisations for MBMPs, although faecal microbiota transplantation is available under clinical trial authorisations and as an unlicensed medicine, often for recurrent Clostridioides difficile infection.
In a press release issued on 18 August 2026, the MHRA said that MBMPs “represent a promising new category of therapies with the potential to address areas of significant unmet clinical need, such as antimicrobial resistance [AMR]”.
It added that it hopes the position paper will help by “encouraging developers to pursue UK licensing pathways for this emerging class of therapies”, adding that MBMPs fall under the existing UK medicines regulatory framework as set out in the Human Medicines Regulations 2012.
The position paper explains the scientific and regulatory steps manufacturers need to consider when developing MBMPs, noting that “given the scientific novelty, regulatory complexity, and potential international divergence in expectations, early engagement with the MHRA is recommended” through its Innovation Office and Scientific Advice services.
Julian Beach, executive director of healthcare quality and access at the MHRA, said: “MBMPs represent one of the most interesting and fast-moving areas in medicine today. Our position paper gives developers the clarity they need to bring these innovations forward with confidence, while ensuring patients continue to be protected by the same rigorous standards that underpin all licensed medicines in the UK.
“The UK’s existing, proportionate and evidence-based licensing frameworks are ready to support this field. Early engagement with us is the best way for developers to navigate it successfully.”
Amira Guirguis, chief scientist at the Royal College of Pharmacy, said: “MBMPs are a promising and emerging area of research, particularly where there is unmet clinical need. The MHRA’s position paper is helpful in providing greater clarity for developers on how these products can be developed and considered within the UK medicines regulatory framework.
“As with any new medicine, it is important that products are supported by robust evidence of their quality, safety and clinical effectiveness before they are used in practice. For microbiome-based medicines, this should also include consideration of challenges such as product consistency, biological variability and potential AMR risks.”
