18
Deferred
Require MHRA to produce guidance on regulating GE phages and enzymes for GMP compliance
Recommendation
For phages to be effective they will need to keep pace with bacterial resistance and be amenable to adaptation for individual patients. Genetically engineered (GE) phages may be one way of ensuring this. GE phages have already been used in the UK and elsewhere. However, if they are to be produced commercially, GE phages will need to be aligned with GMP. We recommend that the MHRA produces guidance on how GE phages will be regulated and how they will meet GMP. The MHRA should also provide guidance on how extracted phage enzymes will meet GMP requirements.
Government Response Summary
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.
Paragraph Reference
88
Government Response
Deferred
Government Response
Deferred
HM Government
Deferred
1. The antimicrobial potential of phages - parliament.uk (https://committees.parliament.uk/work/7045/the-antimicrobial-potential-of- bacteriophages/) 2. Contained and controlled: the UK’s 20-year vision for antimicrobial resistance – GOV.UK (https://www.gov.uk/government/publications/uk-20-year-vision-for-antimicrobial- resistance) 3. 2024 voluntary scheme for branded medicines pricing, access and growth - GOV.UK (https://www.gov.uk/government/publications/2024-voluntary-scheme-for-branded- medicines-pricing-access-and-growth) 4. Pathways to antimicrobial clinical efficacy (PACE) - UKRI (https://www.ukri.org/what-we- do/browse-our-areas-of-investment-and-support/pathways-to-antimicrobial-clinical- efficacy-pace/) 5. Tackling Infections – UKRI (https://www.ukri.org/what-we-do/browse-our-areas-of- investment-and-support/tackling-infections/) 6. 2023 Autumn Statement – GOV.UK (https://www.gov.uk/government/publications/autumn-statement-2023) 7. NHS commercial framework for new medicines - NHS.UK (https://www.england.nhs.uk/publication/nhs-commercial-framework-for-new-medicines/) 8. Commercial clinical trials in the UK: the Lord O’Shaughnessy review - final report - GOV.UK (https://www.gov.uk/government/publications/commercial-clinical-trials-in-the-uk- the-lord-oshaughnessy-review/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy- review-final-report#executive-summary) 9. Guidance: International Recognition Procedure - GOV.UK (https://www.gov.uk/government/publications/international-recognition- procedure/international-recognition-procedure) 10. Written Evidence submitted by DHSC, UKHSA and MHRA to the SITC’s Inquiry: the antimicrobial potential of phages (https://committees.parliament.uk/work/7045/the- antimicrobial-potential-of-bacteriophages/publications/written-evidence/?page=2) E03073385 978-1-5286-4694-9
Source
Report
First Report - The antimicrobial potential of bacteriophages
03 Jan 2024
HC 328
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age
2.4 yrs
Report published
03 Jan 2024