Source · Select Committees · Science, Innovation and Technology Committee
First Report - The antimicrobial potential of bacteriophages
Science, Innovation and Technology Committee
HC 328
Published 3 January 2024
Conclusions (1)
24
Conclusion
Accepted in Part
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. …
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.