The regulator’s new position paper provides developers with a defined regulatory route to licence microbiome-based medicinal products in the UK.
A new position paper from the Medicines and Healthcare products Regulatory Agency (MHRA) is offering a clear route to licencing microbiome-based medicinal products (MBMPs), while maintaining the same robust quality and safety standards of UK medicines.
The paper encourages developers to pursue UK licencing pathways for this promising new category of therapies which can address antimicrobial resistance (AMR). No MBMPs are currently authorised in the UK.
Key recommendations for developers included in the paper are: product characterisation, manufacturing consistency, control of batch-to-batch variability, safety assessment (including antimicrobial resistance risk), and generation of robust clinical evidence.
MBMPs align with the existing UK medicines regulatory framework, set out in the Human Medicines Regulations 2012. Under the MHRA’s new paper, depending on their characteristics, these therapies may be regulated as biological medicinal products, or advanced therapy medicinal products (ATMPs), in certain cases.
The position paper also clarifies existing arrangements for faecal microbiota transplantation (FMT) in the UK, most notably used for recurrent Clostridioides difficile infection.
Our position paper gives developers the clarity they need to bring [microbiome-based medicinal products] forward with confidence, while ensuring patients continue to be protected by the same rigorous standards that underpin all licensed medicines in the UK… Early engagement with us is the best way for developers to navigate it successfully.”
Julian Beach, Executive Director of Healthcare Quality and Access at the MHRA
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.” Specifically, to clarify the applicable regulatory framework, agree proportionate development strategies and de-risk investment decisions ahead of pivotal trials.
The field is also seeing broader developments, including introduction of the Substances of Human Origin (SoHO) Regulation in the EU—a framework for intestinal microbiota interventions.
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