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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

A response document is linked to this report, dated 1 March 2024. Response attribution to this conclusion has not been verified. Read the response document.

Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age 2.7 yrs
Report published 03 Jan 2024