22

Require MHRA to outline regulatory approach for clinical safety of diverse phage scenarios

Recommendation
The MHRA should set out how they propose to regulate and ensure clinical safety for each of the scenarios set out above. This would allow for the narrowing of R&D and production work to prevent wasted effort and allow an agile approach, allowing non-generic phage production for specific patients but GMP production for phages to mitigate the most common bacterial pathogens causing AMR in humans, animals and the environment.
Paragraph Reference
101
Government Response

A response document is linked to this report, dated 1 March 2024. Response attribution to this recommendation 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