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The MHRA has published a position paper setting out how microbiome-based medicinal products (MBMP) can be made available for UK patients, saying it encourages developers to pursue licences for these “promising” emerging therapies.

MBMPs, which modulate, restore or replace the human microbiome, have the potential to “address areas of significant unmet clinical need” such as antimicrobial resistance, said the UK medicines agency, adding that some countries have authorised “a small number of donor-derived microbiota products” to treat C. difficile infection.

The MHRA said it takes the position that these products fall within the scope of existing medicines regulations, giving manufacturers “a clear route to licencing” while adhering to “robust standards” around safety and efficacy.

MBMPs can either be classed as biological medicines or advanced therapy medicinal products, it said, adding that no such products have yet received UK marketing authorisation.

In addition to encouraging developers to make use of its Innovation Office and Scientific Advice services to help form strategies and de-risk investment decisions ahead of clinical trials, in its position paper the MHRA clarified the existing arrangements for faecal microbiota transplantation (FMT) for indications such as recurrent C. difficile.

The MHRA’s Julian Beach said: “Microbiome-based medicinal products 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.”