The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 18 August 2026, issued a position paper clarifying the UK licensing pathway for microbiome-based medicinal products (MBMPs). This aims to encourage developers to pursue UK authorisation for these new therapies.
MBMPs are medicines designed to work by modulating, restoring, or replacing the human microbiome. They are considered a promising new category with potential to address areas of unmet clinical need, including antimicrobial resistance.
The MHRA states that MBMPs fall within the scope of the existing UK medicines regulatory framework, specifically the Human Medicines Regulations 2012. This framework provides a clear route to licensing while maintaining established standards for quality, safety, and efficacy. Depending on their characteristics, MBMPs may be regulated as biological medicinal products or, in some cases, as advanced therapy medicinal products (ATMPs).
Currently, no MBMP holds a UK marketing authorisation. The position paper outlines key scientific and regulatory steps for developers, including product characterisation, manufacturing consistency, safety assessment, and the generation of robust clinical evidence.
Julian Beach, Executive Director of Healthcare Quality and Access at the MHRA, stated that the paper provides developers with clarity to advance these innovations, while ensuring patient protection. He encouraged early engagement with the MHRA's Innovation Office and Scientific Advice services.
The paper also clarifies existing arrangements for faecal microbiota transplantation (FMT) in the UK. FMT, used for specific indications like recurrent Clostridioides difficile infection, remains available through clinical trials or as an unlicensed medicine under MHRA arrangements, and these routes are unaffected by the new publication.