Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what information his Department holds on (a) when the Medicines and Healthcare products Regulatory Agency plans to publish guidance on regulatory process for phage therapy use; and (b) whether that guidance will help reduce regulation on phage therapy research.

The Medicines and Healthcare products Regulatory Agency (MHRA) is preparing the draft guidance, Regulatory considerations for therapeutic use of bacteriophages in the United Kingdom, which will be published in the second quarter of 2025.

Regulation of medicines in the UK is undertaken by the MHRA in accordance with the Human Medicines Regulations 2012 (SI 2012/1916) (as amended), thereby ensuring compliance with statutory obligations relating to the manufacture, distribution, sale, labelling, advertising, and promotion of medicines.

The purpose of the guidance is to address regulatory considerations applicable to the use, in the UK, of bacteriophages for therapeutic purposes in humans, whether as licensed or unlicensed medicinal products.