30
Deferred
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.
Government Response Summary
The government reiterates that all medicines must be manufactured to GMP and states that new non-binding advisory guidance is under development by MHRA. However, the production of a monograph specifically for non-GMP phages, as recommended, will be deferred.
Paragraph Reference
129
Government Response
Deferred
Government Response
Deferred
HM Government
Deferred
All medicines are required to be manufactured to GMP but may be provided outside of the marketing authorisation framework as unlicensed medicines on an individual patient basis. In the UK, all imported unlicensed medicines including those that may incorporate bacteriophages are currently subject to review to ensure that they have been manufactured at equivalent standards to, or in compliance with, GMP regulations. New non-binding advisory guidance is under development by MHRA. The production of a monograph will be deferred until MHRA has gained experience from writing the non-binding advisory guidance.
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