24
Accepted in Part
Good Manufacturing Practice requirements create impasse for UK phage development
Conclusion
One of the major obstacles to phage clinical trials in the UK has been the requirement for GMP phages. However, regulators require that for phages to achieve GMP standards they must themselves have first been subject to clinical trials. This impasse is stalling the development of phages in the UK. The Department of Health and Social Care should consider investing in a small GMP facility which would solve one part of the problem. However, it would not solve the issue of UK GMP requiring clinical trials that in themselves had to use GMP phages. Clarity is needed on how this conundrum can be solved. (Paragraph 105) The antimicrobial potential of bacteriophages 61
Government Response Summary
The government states that MHRA's draft non-binding advisory guidance will define standards for licensed phages and clarifies that phages for named-patient use require GMP standards but not clinical trials or marketing authorization, thus providing clarity on the described conundrum.
Government Response
Accepted in Part
Government Response
Accepted in Part
HM Government
Accepted in Part
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