Julian Beach: Bacteriophages have huge potential as a new way to treat bacterial infections, especially as antibiotic resistance to existing treatments grows. In the future, phages could become a first-line treatment option in some settings, or a backup when antibiotics don’t work.

Phage therapy may take many forms, including personalized treatments, and presents unique challenges – there are currently no licensed phage products in the UK but it is important that the regulatory pathways are defined and communicated to product developers.

There’s increasing interest from both clinicians and industry in developing these therapies, but we’ve heard from developers that they need more clarity on how the UK regulatory framework applies to phages. This new guidance responds to that need – it’s about supporting safe, effective innovation.

The document has also been compiled in response to recommendations made by the UK House of Commons Science, Innovation, and Technology Committee inquiry.

Our aim is to ensure patients can benefit from safe, effective bacteriophage therapies as the field develops.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

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