Source · Select Committees · Science and Technology Committee (Commons)
Recommendation 18
18
Paragraph: 88
Require MHRA to produce guidance on regulating GE phages and enzymes for GMP compliance
Recommendation
For phages to be effective they will need to keep pace with bacterial resistance and be amenable to adaptation for individual patients. Genetically engineered (GE) phages may be one way of ensuring this. GE phages have already been used in the UK and elsewhere. However, if they are to be produced commercially, GE phages will need to be aligned with GMP. We recommend that the MHRA produces guidance on how GE phages will be regulated and how they will meet GMP. The MHRA should also provide guidance on how extracted phage enzymes will meet GMP requirements.
Paragraph Reference:
88
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 ↗