First Report - The antimicrobial potential of bacteriophages

The MHRA committed to providing non-binding advisory guidance on the specific data needed to evaluate licensed phage products for NHS use. The government also confirmed it will continue to engage with phage stakeholders through the Innovate UK KTN Phage Innovation Network.

The government supports the principle of phage education but states that medical and veterinary training standards and curricula are the responsibility of independent statutory bodies (GMC, RCVS, and schools), thereby deflecting responsibility. It does not address the recommendation to review phages within AMR plans or NIHR/UKHSA engagement.

The government explains that NIHR does not ringfence funding and awards depend on application quality, noting few past applications for phage research. It states that NIHR and DHSC are exploring approaches with UKRI to improve phage research capacity, but does not commit to a specific review of funding bottlenecks or dedicated funding.

The government rejects the recommendation to produce annual reports exclusively focused on phages, stating it is reluctant to prioritize any one technology, but will regularly review progress on its 5-year AMR National Action Plan, which will include phages.

The government states it has committed to establishing general clinical trial acceleration networks with funding, but does not specifically address responding to the Phage Knowledge Transfer Network's proposals or developing a phage-specific knowledge sharing network or biobanks.

The government supports the principle of education and training on phages but redirects responsibility for medical and veterinary training standards and curricula to the independent General Medical Council, Royal College of Veterinary Surgeons, and medical schools.

The government supports training on phage therapy but redirects responsibility for medical and veterinary training standards to the General Medical Council (GMC) and the Royal College of Veterinary Surgeons (RCVS), stating they determine curriculum content.

The government states that GMP requirements remain appropriate for named-patient use, thereby rejecting the committee's suggestion for non-GMP phages for compassionate use. It notes MHRA guidance for licensed products is in development.

The government indicates DHSC should review current guidance for non-GMP phages, and MHRA is developing new non-binding advisory guidance for them. However, it does not address the recommendation to build a GMP facility or invest in existing spaces for phage production, nor the question of pharmaceutical company investment.

The government states that the MHRA is developing non-binding advisory guidance for the licensing requirements of phage products, which will address regulatory frameworks and genetic modifications, with public input.

The government's response consists solely of a list of references and links, providing no specific textual reply or commitment regarding guidance for GE phages or extracted phage enzymes.

The government rejects the premise of regulating non-GMP phages, stating all medicines must be manufactured to GMP standards. It clarifies that specific developmental pathways are not needed for compassionate use phages and that MHRA guidance under development will provide information on manufacturing phage-based medicinal products to GMP.

The government states that MHRA non-binding advisory guidance for licensed phage products is in development, scheduled for public consultation in 2024, and will define safety tests and extrapolation for bacteriophages. It also confirms GMP requirements for named-patient use.

The government commits to reviewing clinical trial legislation, with accompanying guidance to be published in 2024, and is establishing clinical trial acceleration networks to support innovation and new ways of delivering trials.

The government states that the MHRA's draft non-binding advisory guidance on phage regulation, intended for public consultation later this year, will define quality, safety, and efficacy standards for licensed phages. It also clarifies that phages for named-patient use require GMP standards but not clinical trials.

The government states that the NIHR offers an existing Research Support Service for researchers, including those working on phages, and that MHRA's upcoming guidance will recommend sponsors engage with them for scientific advice, which MHRA already provides.

The government states that the MHRA has mutual recognition agreements and has introduced the International Recognition Procedure (IRP) from January 2024, which allows it to recognise the decision-making of trusted reference regulators to expedite market approval for products in the UK.

The government states new non-binding advisory guidance on phage regulation is under development by MHRA, but the production of a monograph will be deferred until MHRA gains experience from this guidance.

The government rejects allowing non-GMP phages for compassionate use, stating all medicines must meet GMP standards, and defers the production of a monograph until MHRA gains experience from developing new advisory guidance.

The government reiterates that all medicines must be manufactured to GMP and states that new non-binding advisory guidance is under development by MHRA. However, the production of a monograph specifically for non-GMP phages, as recommended, will be deferred.

The government rejects the recommendation, stating that regulation for pharmacy practice is beyond the remit of the MHRA and that liability for unlicensed medicines currently rests with the prescriber.

The government rejects producing a further definitive statement on phages or a roadmap at this time, stating it will continue to monitor developments and include phages as one of many research areas in the upcoming AMR national action plan.

The government rejects producing a new clear statement on phages or a comprehensive plan for their support and regulatory landscape at this time. It states that existing evidence is promising but requires more robust data, and that phages will be recognised in the upcoming 2024-2029 AMR national action plan.