17 Accepted

Require MHRA to provide guidance on regulating phage cocktails based on individual ingredients

Recommendation
We recommend that the MHRA provides guidance on how phage cocktails will be regulated. It should consider the case of influenza vaccines, and allow phage permutations to be assessed on the basis of their individual constituent ingredients meeting agreed purity and safety standards and not for each new combination of those ingredients.
Government Response Summary
The government states that the MHRA is developing non-binding advisory guidance for the licensing requirements of phage products, which will address regulatory frameworks and genetic modifications, with public input.
Paragraph Reference
86
Government Response
Accepted
HM Government Accepted
The MHRA is developing non-binding advisory guidance for the licensing requirements for phage products, which will include input from the public. This guidance will be updated in consultation with the phage research and development community as the products and associated methods and technologies mature and in the light of regulatory experience. Genetic modifications influence which regulatory frameworks will apply during phage manufacture. This will be clarified in the MHRA non-binding advisory draft guidance. Genetically engineered (GE) bacteriophages are most likely to be a constituent of licensed products, and, therefore, subject to GMP (all licensed products are currently subject to GMP). It is unlikely that GE phages will be used in named patient or compassionate use cases due to the time needed to engineer and validate them. Phage-derived proteins and other materials sit under the biologicals regulatory framework alongside products such as monoclonal antibodies, cytokines, and recombinant coagulation factors. The requirements of a fit-for-purpose regulatory framework for phage-based medicines are already under consideration by the VMD. This includes the consideration of guidance for the manufacturers and developers of phage-based VMPs. Existing requirements and risk assessments for formulations of VMPs, including genetically modified organisms (GMOs), will be reviewed to ensure they are appropriate for VMPs containing GE phages. However, there is little concern regarding the functionality of the existing framework, given that genetically modified viral vaccines have been successfully and safely authorised in the UK for many years for use in animals.
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age 2.4 yrs
Report published 03 Jan 2024