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Bacteriophages

Answer

In the March 2024 response to the Science, Innovation and Technology Committee’s report on bacteriophages, the government acknowledged the challenges in developing phage therapy in the United Kingdom, including the requirement to meet Good Manufacturing Practice (GMP) standards. GMP is the minimum standard that a medicines manufacturer must meet in their production processes. To meet GMP, products must:

- be of consistent high quality;

- be appropriate to their intended use; and

- meet the requirements of the marketing authorisation or product specification.

In the response, the Government committed to considering the case for a UK-based GMP facility to support phage innovators and reduce reliance on imports. The UK Health Security Agency is also exploring phage production options in accordance with GMP, working with partners nationally and internationally.

The new Life Sciences Sector Plan, part of the upcoming Industrial Strategy, to be published in late spring 2025, will outline the Government’s growth strategy for the sector. Within this, domestic manufacturing, including for bacteriophage production, is a priority and projects can be supported via applications to the Life Sciences Innovative Manufacturing Fund.

In parallel, the Medicines and Healthcare products Regulatory Agency will be publishing draft guidance on phage product licensing, developed with researchers and industry, to clarify regulatory and manufacturing requirements.

Secondary information

Type

Written question

Reference

44133

Session

2024-26

Subjects

Imports Medical treatments National security Bacterial diseases Bacteriophages

Link

View this Written question on www.parliament.uk