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Written question asked by Martin Wrigley (Liberal Democrat) on Tuesday, 8 April 2025, in the House of Commons. It was due for an answer on Tuesday, 22 April 2025. It was answered by Karin Smyth (Labour) on Tuesday, 22 April 2025 on behalf of the Department of Health and Social Care.


Bacteriophages

Question

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.

Answer

The Medicines and Healthcare products Regulatory Agency (MHRA) is preparing the draft guidance, Regulatory considerations for therapeutic use of bacteriophages in the United Kingdom, which will be published in the second quarter of 2025.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


Secondary information

Type
Written question
Reference
45223
Session
2024-26
Subjects
Medical treatments Research Regulation Bacterial diseases Bacteriophages
Link
View this Written question on www.parliament.uk