The Medicines and Healthcare products Regulatory Agency has published a new position paper confirming that microbiome-based medicinal products can be licensed through existing UK medicines regulations, providing greater certainty for developers seeking to bring these innovative therapies to market.
The announcement is designed to support investment and development in what is widely regarded as one of the most promising areas of modern medicine. Microbiome-based medicines work by modulating, restoring or replacing components of the human microbiome and have the potential to transform treatment options across a range of conditions, including those linked to antimicrobial resistance (AMR).
According to the MHRA, MBMPs already fall within the scope of the UK's existing regulatory framework under the Human Medicines Regulations 2012. This means developers do not need an entirely new regulatory pathway and can instead pursue established licensing routes while meeting the same standards of quality, safety and efficacy required for all medicines authorised in the UK.
Depending on their characteristics, microbiome-based medicinal products may be regulated as biological medicinal products or, in some cases, as advanced therapy medicinal products.
Currently, no microbiome-based medicinal product holds a UK marketing authorisation. However, several donor-derived microbiota products have already been authorised internationally for the treatment of Clostridioides difficile (C. difficile) infection.
The MHRA's position paper highlights several areas that companies should address during development, including:
- Product characterisation and composition
- Manufacturing consistency and quality controls
- Management of batch-to-batch variability
- Safety assessments, including antimicrobial resistance risks
- Generation of robust clinical evidence to support regulatory approval
The regulator believes that providing clarity at this stage will help accelerate innovation while ensuring patient safety remains paramount.
Julian Beach, Executive Director of Healthcare Quality and Access at the MHRA, 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.”
The MHRA is encouraging companies developing microbiome-based therapies to engage with its Innovation Office and Scientific Advice services as early as possible. The agency says this can help organisations determine the most appropriate regulatory route, establish proportionate development plans and reduce risk ahead of pivotal clinical trials.
The publication also confirms that existing arrangements for faecal microbiota transplantation in the UK will continue unchanged.
FMT is currently used in specific clinical situations, particularly recurrent Clostridioides difficile infection, and may be supplied through clinical trials, under MHRA "specials" manufacturing arrangements, or through extemporaneous preparation. In all cases, responsibility remains with the prescribing clinician.
The MHRA also highlighted ongoing international developments, including the European Union's forthcoming Substances of Human Origin Regulation, which will introduce a dedicated framework for intestinal microbiota interventions across EU member states.
For UK developers, the regulator's latest position provides much-needed certainty and signals that Britain intends to remain an attractive destination for microbiome innovation, investment and clinical development.
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