The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has published the country's first official guidance for developing phage therapies, marking a significant regulatory milestone in the fight against antibiotic-resistant infections. The guidance, released on June 4, aims to accelerate the development of treatments that use viruses to target and destroy harmful bacteria.
Addressing Critical Medical Need
With over 60,000 serious antibiotic-resistant infections estimated annually in the UK and growing, the guidance addresses an urgent medical need. Lawrence Tallon, MHRA Chief Executive, emphasized the critical nature of this challenge: "Some infections are becoming harder to treat when antibiotics are ineffective against them – and patients urgently need new options."
The guidance covers both combined phage products designed for common infections and circulating strains, as well as personalized phage therapies tailored for individual patients with rare or highly resistant infections. For patients, this could mean access to phage treatment when standard-of-care antibiotics fail or cannot be given due to allergies.
Regulatory Framework and Development Support
The 28-page document brings together UK and international regulatory standards, providing clear practical advice on requirements at each stage of development. The guidance details what evidence is needed to support clinical trials and market authorization, how to meet standards on quality, safety and manufacturing including Good Manufacturing Practice (GMP), and when unlicensed phage treatments can be used for individual patients.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, noted that "developers have told us they need clarity on how phage therapies fit into the UK's regulatory system. This helps signpost relevant requirements, providing that clarity."
Current Treatment Landscape
While some patients in the UK have already received phage therapy under compassionate use with phages imported from abroad, there are currently no licensed phage medicines on the UK market. Phage therapies use bacterial viruses called bacteriophages that attack specific bacteria without harming human cells, making them a promising complement to existing treatments.
Industry and Expert Response
The guidance development involved input from the Phage Innovation Network, a cross-sector group supported by Innovate UK, along with industry, clinicians and academic researchers. Frederique Vieville, BEAM Alliance Phage ACT Lead and 5QBD-Biotech Chief Executive, highlighted the importance of regulatory clarity: "Clarity about the pathway – tailored to the unique characteristics of phages – is vital to help meet quality, non-clinical, and clinical requirements, and ultimately bring phage-based treatments to patients more efficiently."
Dr. Jason Clark, NexaBiome Director and Chief Scientific Officer, praised the guidance as "incredibly forward-thinking" and noted it "puts the UK in pole position to fully realise the healthcare and commercial benefits of this exciting technology."
Supporting UK's AMR Strategy
The publication supports the UK's antimicrobial resistance strategy and the MHRA's role in enabling innovative, science-led regulation. Dr. Colin Brown, deputy director at the UK Health Security Agency responsible for AMR, stated that "phage therapy truly has the potential to transform the way we treat bacterial infections, especially as resistance to antibiotics grows."
The UK Health Security Agency is developing new ways to increase phage therapy use and research, including a bacteriophage collection where scientists can both access and deposit phages, with hopes that solutions like phage therapy can become first-line treatment options.
Companies interested in developing bacteriophage treatments can access scientific advice from the MHRA at any stage of development, supporting the UK's mission to become a world leader in life sciences innovation.
