MHRA Sets Out UK Licensing Route for Microbiome Medicines

The Medicines and Healthcare products Regulatory Agency published a position paper on 18 August 2026 setting out how microbiome-based medicines can be licensed for use in the UK. The paper confirms that these products, which work by modulating, restoring or replacing the human microbiome, already sit inside the existing framework created by the Human Medicines Regulations 2012, so developers do not have to wait for a separate regulatory system to be built for them. Depending on how a product is made and what it contains, the MHRA says it may be regulated either as a biological medicinal product or as an advanced therapy medicinal product, with the same quality, safety and efficacy requirements applied in each case. Julian Beach, the MHRA's Executive Director of Healthcare Quality and Access, said: "The UK's existing, proportionate and evidence-based licensing frameworks are ready to support this field." No microbiome-based medicinal product currently holds a UK marketing authorisation.

What the MHRA is asking developers to show

The position paper lists the scientific and regulatory steps the agency expects developers to work through: product characterisation, manufacturing consistency, control of batch-to-batch variability, safety assessment including antimicrobial resistance risk, and clinical evidence. The MHRA names antimicrobial resistance as one area of unmet need this class of product might eventually address. Arrangements for faecal microbiota transplant are unchanged, and it continues to be supplied through clinical trials, through MHRA "specials" manufacturing, or by extemporaneous preparation, with responsibility resting with the prescribing clinician. Developers are encouraged to contact the agency's Innovation Office and Scientific Advice services early. A small number of donor-derived microbiota products have been authorised in other countries for Clostridioides difficile infection.

What this means for your supplement routine

The paper is about licensed medicines, not about food supplements, and it does not discuss probiotics at all. Probiotic products sold in the UK, including those across Perqen's full supplement catalogue, are regulated as food rather than as medicines, and nothing in this announcement changes that. What the paper does is make the dividing line more visible. A product presented as treating a condition by altering the microbiome is heading towards a marketing authorisation and the clinical evidence that goes with one. A probiotic food supplement is not, and the claims it may carry are limited to authorised wording, which in Great Britain means the GB Nutrition and Health Claims Register and in Northern Ireland the EU register. For shoppers, the practical read is that the two categories are becoming easier to tell apart, not that one is turning into the other.

How Perqen members save

Perqen membership costs £4.99 a month or £29.99 a year and unlocks member pricing across the whole 1,393-product range, with non-members still able to buy at standard prices. Full terms are on the membership page.

This article reports published news and research and is for information only. Food supplements are not a substitute for a varied diet or medical care, and no product mentioned is intended to diagnose, treat, cure or prevent any disease. Speak to your GP or pharmacist before changing what you take, especially if you are pregnant, breastfeeding, or taking prescribed medicines.

Sources

• MHRA sets out position on regulation of microbiome-based medicinal products
• MHRA clarifies UK licensing route for microbiome-based medicines

Originally reported by MHRA (GOV.UK). This article has been reviewed by Dr Tosin.