# Regulatory considerations for therapeutic use of bacteriophages in the UK

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/c27bfecf-bfb4-4171-a126-6f8e2bfa0a0f
Type: Guidance
Published: June 3, 2025
Updated: November 3, 2025

> The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released a comprehensive guidance document designed to centralize regulatory requirements for the development of phage therapeutic products. This publication acts as a unified resource for developers navigating the complex regulatory framework governing both licensed and unlicensed medicines. Unlike an enforcement report involving specific company violations or inspection dates, this document focuses on establishing clear standards across the entire product lifecycle, from preclinical research to post-licensure pharmacovigilance. The MHRA acknowledges that while regulatory documentation exists, it is often difficult for developers to locate or interpret; consequently, this consolidation aims to clarify the path to compliance. Key areas addressed include rigorous preclinical testing, safety assessments, and the maintenance of robust monitoring systems once a product enters the market. Developers are expected to follow these consolidated guidelines to ensure their products meet the safety and efficacy standards necessary for patient use. By streamlining access to these regulatory expectations, the MHRA intends to support the advancement of phage therapies and accelerate the delivery of innovative treatments to patients. This centralized approach reduces the burden on developers and ensures a consistent application of medicinal standards within the United Kingdom.

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## Content

The MHRA has compiled a document containing all the relevant regulatory guidance pertinent to the development of phage therapeutic products. Regulatory agencies and organisations have produced documentation to help outline the regulatory framework, but regulatory guidance is not always easy for product developers to find and/or understand; this publication brings all the pertinent regulatory information into one place. The MHRA document includes guidance for licensed and unlicensed medicines, from preclinical development to pharmacovigilance activities post-licensure. We hope that this publication will help the community navigate the regulatory frameworks and support the development of products that will ultimately help patients.

## Attachments

- [Regulatory considerations for therapeutic use of bacteriophages in the UK](https://assets.publishing.service.gov.uk/media/6908ce9c5e080b12248981a2/regulatory_considerations_for_therapeutic_use_of_bacteriophages_in_the_UK.pdf)