The UK Medicines and Healthcare products Regulatory Agency (MHRA) published a position paper on 18 August 2026 stating that microbiome-based medicinal products (MBMPs) fall within the existing UK medicines framework set out in the Human Medicines Regulations 2012. The agency said this gives developers a clear licensing route while keeping the same quality, safety and efficacy standards applied to all UK medicines.

According to the MHRA, MBMPs may be regulated as biological medicinal products or, in some cases, meet the criteria for advanced therapy medicinal products. The paper notes that no MBMP held a UK marketing authorisation at that date, and that some countries have authorised a small number of donor-derived microbiota products for Clostridioides difficile infection.

Julian Beach, the MHRA's Executive Director of Healthcare Quality and Access, said the paper gives developers clarity while maintaining patient protections. The agency listed product characterisation, manufacturing consistency, batch-to-batch variability, safety assessment including antimicrobial resistance risk, and clinical evidence among steps developers should consider. The MHRA said arrangements for faecal microbiota transplantation, currently supplied through clinical trials or as an unlicensed medicine, were unaffected by the publication.