The position paper says that microbiome-based medicinal products fall within the scope of the existing UK medicines regulatory framework.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a position paper clarifying how microbiome-based medicines can be made available for patients in the UK. 

Microbiome-based medicinal products are medicines that work through modulating, restoring or replacing the human microbiome. They represent a promising new category of therapies with the potential to address areas of significant unmet clinical need such as antimicrobial resistance (AMR). 

The MHRA’s position is that MBMPs fall within the scope of the existing UK medicines regulatory framework. This provides developers with a clear route to licensing. Depending on their characteristics, microbiome-based medicines may be regulated as biological medicinal products, or in some cases may meet the criteria for advanced therapy medicinal products (ATMPs). 

“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,” said Julian Beach, executive director of healthcare quality and access at the MHRA. 

No MBMP currently holds a UK marketing authorisation. Some countries have authorised a small number of donor-derived microbiota products for Clostridioides difficile (C. difficile) infection.  

The position paper also clarifies existing arrangements for faecal microbiota transplantation. It is currently used for specific indications, most notably recurrent clostridioides difficile infection, and is supplied either through clinical trials or as an unlicensed medicine under MHRA “specials” manufacturing arrangements or extemporaneous preparation. These routes remain under the direct responsibility of the prescribing clinician and are unaffected by today’s publication.