MHRA issues first UK guidance on phage therapies
Posted: 5 June 2025 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
MHRA’s publication is intended to support European developers of phage-based medicinal products to effectively navigate related regulations.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published the UK’s first official guidance on safe development and use of phage therapies.
The publication collates UK and international regulatory standards on phage therapies into one place. The document was developed in collaboration with the Phage Innovation Network, industry, clinicians and academic researchers.
MHRA’s guidance is an important step as the UK does not have any licensed phage medicines at present. It also supports the UK 2024-2029 National Action Plan in addressing antimicrobial resistance (AMR) and the organisation’s wider role in ensuring safe, high-quality medicines.
“Developers have told us they need clarity on how phage therapies fit into the UK’s regulatory system. [The MHRA’s guidance] helps signpost relevant requirements, providing that clarity”
“Recent steps have been taken by European regulators to outline the regulatory framework for phage-based medicinal products, but developers still need support to navigate it effectively,” remarked Frederique Vieville, BEAM Alliance Phage ACT Lead, a European group supporting antimicrobial therapy development, and 5QBD-Biotech Chief Executive, a biotech company focused on bacteriophage therapies.
Phage therapy developers “have told us they need clarity on how phage therapies fit into the UK’s regulatory system. This helps signpost relevant requirements, providing that clarity,” explained Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access.
“As a Company developing bacteriophage products for human use, this guidance helps us to decrease perceived risks and gives clarity to the regulatory landscape, ultimately enabling us to more readily bring investment into the UK,” stated Dr Jason Clark, Director and Chief Scientific Officer of UK phage therapy developer NexaBiome.
The new guidance from the MHRA provides recommendations including:
- which evidence is required to support clinical trials and market authorisation
- compliance of quality, safety and manufacturing standards for phage therapies, such as Good Manufacturing Practice (GMP)
- developing and supplying personalised phage-based treatments
Related topics
Antibiotics, Big Pharma, Biopharmaceuticals, Clinical Development, Clinical Trials, Drug Manufacturing, Drug Markets, Drug Safety, Good Manufacturing Practice (GMP), Industry Insight, Manufacturing, Regulation & Legislation, Research & Development (R&D), Therapeutics
