The UK has taken a major step in the fight against antibiotic-resistant infections by releasing the first official guidance on the development and use of phage therapy.
The document, published by the Medicines and Healthcare Products Regulatory Agency (MHRA), outlines how researchers and pharmaceutical companies can safely bring these virus-based treatments to patients.
Commenting on the transformational guidance, MHRA CEO Lawrence Talon said:
“Phage therapy is one of several promising approaches. This guidance can bring together relevant criteria to provide clarity to researchers and businesses, and safely develop these treatments and take them to those in need.
“We are committed to working with the industry to support innovation in this area. We will not compromise on the robust safety and quality standards that patients expect right and expected. Supporting innovation and making the UK a world leader in life sciences is part of our broader mission.”
What is phage therapy?
Phage therapy uses bacteriophages (viruses that target and destroy certain bacteria) that provide a powerful alternative when antibiotics fail.
Unlike broad-spectrum antibiotics, phages act accurately, leaving human cells and beneficial bacteria intact.
With over 60,000 serious antibiotic-resistant infections occurring every year in the UK, interest in these tailored treatments is growing rapidly.
Personalized and combined phage treatment
MHRA guidance addresses two major approaches: Two major phage therapies are rare or drug-resistant infection patients and combinations of phage products aimed at a more common bacterial threat.
These treatments can save lives when standard antibiotics are ineffective or inappropriate, such as those that involve allergies.
Some UK patients have already undergone phage therapy during compassionate use with imported products, but there are currently no licensed phage therapy on the UK market. This guidance shows an important move to change the landscape.
Clear Roadmap for Developers
The 28-page publication provides practical, step-by-step advice covering every stage of phage therapy development, from early research to clinical use.
It details regulatory expectations for clinical trial evidence, manufacturing standards under excellent manufacturing operations (GMP), and personalized routes of treatment.
Importantly, it explains how unlicensed treatments can be administered on a case-by-case basis under the supervision of a clinician.
Dr. Colin Brown, assistant director of the UK Health and Security Agency, responsible for AMR, added: “The new guidance from MHRA will help lay the foundation for opportunities for phage therapy in the UK, providing much needed direction for scientists and researchers working to make this treatment a reality for patients.
“Phage therapy has the potential to change the way bacterial infections are treated, especially as resistance to antibiotics increases. The UKHSA is developing new methods to increase the use and research of phage therapy, such as bacteriophage collection, which allows scientists to access and deposit phages.
“We hope that in the future, solutions like phage therapy will become first-line treatment options.”
Supports innovation and public health
The initiative reflects MHRA’s commitment to supporting the UK’s 2024-2029 national action plan for antibiotic resistance (AMR) and enabling innovative, science-driven healthcare solutions.
Developed in collaboration with the Phage Innovation Network and other key stakeholders, this guidance is expected to accelerate the availability of phage-based drugs while maintaining strict safety and quality standards.
Developers interested in treating bacteriophages can seek scientific advice directly from the MHRA at any stage of development, paving the way for new breakthroughs in infection control.
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