27
Accepted
Require MHRA to outline use of international and non-health data for phage regulation
Recommendation
We are pleased that the MHRA is open to using phage data from a variety of sources as long as it is of sufficient quality. We recommend that the MHRA outlines how it will use clinical data from other countries and non-health evidence to inform its decision-making on regulating phages. (Paragraph 113) The Clinical use of phages in the UK
Government Response Summary
The government states that the MHRA has mutual recognition agreements and has introduced the International Recognition Procedure (IRP) from January 2024, which allows it to recognise the decision-making of trusted reference regulators to expedite market approval for products in the UK.
Government Response
Accepted
Government Response
Accepted
HM Government
Accepted
The MHRA has mutual recognition agreements with several competent authorities to expedite market approval in the UK for products approved in other territories (9). The International Recognition Procedure (IRP) introduced on 1 January 2024 allows the MHRA to recognise the decision-making of 7 trusted reference regulators. The MHRA conducts a targeted assessment of IRP applications and retains the authority to make a sovereign decision.
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