25
Accepted
Require MHRA to clarify phage standards for clinical trials and GMP acquisition
Recommendation
We recommend that the MHRA sets out what standard of phages will be required for UK clinical trials and how GMP will be acquired by UK produced phages if they cannot be assessed by a clinical trial. This guidance should be published within six months of the publication of this report.
Government Response Summary
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.
Paragraph Reference
106
Government Response
Accepted
Government Response
Accepted
HM Government
Accepted
Quality, safety, and efficacy standards for licensed phages will be defined the MHRA’s draft non-binding advisory guidance on phage regulation, which is intended to be published for public consultation later this year. Engagement with the MHRA clinical trials team to discuss clinical trial design is recommended for many products. Phages used in named-patient use will need to meet GMP standards but do not require clinical trials or a marketing authorisation.
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