29 Rejected

Compassionate use of UK-produced non-GMP phages should be permitted for last resort cases

Recommendation
We believe that the UK should allow the compassionate use of non-GMP phages produced in the UK for last resort medical cases where other medical approaches have failed or are failing. This would bring the UK in line with several EU countries, and the USA and Australia. The UK can learn from these countries in ensuring that phages are produced to a high standard, albeit not to the exacting standard of GMP. Using monographs, as is the case in Belgium, that stipulate safety and purity standards, would be an ideal starting place. It could build upon existing guidance for the use of unlicensed specials (products that have not been assessed by the regulatory authority for safety, quality and efficacy in the same way as licensed products) within UK clinical settings and oversight procedures within hospitals. (Paragraph 128) 62 The antimicrobial potential of bacteriophages
Government Response Summary
The government rejects allowing non-GMP phages for compassionate use, stating all medicines must meet GMP standards, and defers the production of a monograph until MHRA gains experience from developing new advisory guidance.
Government Response
Rejected
HM Government Rejected
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.
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age 2.4 yrs
Report published 03 Jan 2024