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Require MHRA to review and regulate UK non-GMP phages for compassionate use, producing monograph

Recommendation
We recommend that the Medicines and Healthcare products Regulatory Agency (MHRA) revisits the regulation of the clinical use of non-GMP phages produced in the UK for last resort compassionate cases where antibiotics or other antibacterial interventions have failed. The MHRA should review the use of non-GMP phages in such cases in other countries and produce a monograph to govern and ensure their safety and purity. The MHRA should publish its review and proposals for a non-GMP phage monograph and any changes that will be required to change necessary regulation to underpin this change. The Department for Health and Social Care should review and report on what changes, if any, will be required to ensure that current guidance and oversight procedures are sufficient for the preparation and use of UK produced non-GMP phages in UK healthcare settings.
Paragraph Reference
129
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