Evidence map›Paper›PMID 41230949›Full record

ReviewMicrobiology (Reading, England)2025

Interpretation guidance for MHRA regulatory considerations for phage therapeutic products.

Carmen Coxon, Elizabeth Bell, Evelien Adriaenssens, Jason Clark, Joe Edwards, Tas Gohir, Francesca Hodges, Josh Jones, Cath Rees, Annette Sansom and 4 more

Erratum issuedAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Microbiology (Reading, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Realizing phage therapy in the UK.Nature microbiology · 2026
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Carmen CoxonMHRA Science Campus, Blanche Lane, South Mimms, Potters Bar, Hertfordshire, EN6 EQG, UK.
Elizabeth BellNational Institute for Health and Care Excellence, Manchester, UK.
Evelien AdriaenssensInnovate UK Phage Innovation Network Advisory Group, Unit 218, Business Design Centre, 52 Upper Street, Islington, London N1 0QH, UK.
Jason ClarkInnovate UK Phage Innovation Network Advisory Group, Unit 218, Business Design Centre, 52 Upper Street, Islington, London N1 0QH, UK.
Joe EdwardsInnovate UK Phage Innovation Network Advisory Group, Unit 218, Business Design Centre, 52 Upper Street, Islington, London N1 0QH, UK.
Tas GohirInnovate UK Phage Innovation Network Advisory Group, Unit 218, Business Design Centre, 52 Upper Street, Islington, London N1 0QH, UK.
Francesca HodgesInnovate UK Phage Innovation Network Advisory Group, Unit 218, Business Design Centre, 52 Upper Street, Islington, London N1 0QH, UK.
Josh JonesInnovate UK Phage Innovation Network Advisory Group, Unit 218, Business Design Centre, 52 Upper Street, Islington, London N1 0QH, UK.
Cath ReesSchool of Biosciences, University of Nottingham, Nottingham, UK.
Annette SansomCampden BRI, Station Road, Chipping Campden, Gloucestershire GL55 6LD, UK.
Darren SmithApplied Sciences, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK.
Mark SuttonInstitute of Pharmaceutical Sciences, King's College London, London, UK.
Clare TrippettUniversity of the West of England, Bristol, Coldharbour Lane, BS16 1QY, UK.
Dann TurnerSchool of Applied Sciences, College of Health, Science and Society, University of the West of England, Bristol, Coldharbour Lane, BS16 1QY, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

On 4 June 2025, the MHRA published 'Regulatory considerations for therapeutic use of bacteriophages in the UK'. This was in response to recommendations made by the House of Commons Science, Innovation and Technology Committee Inquiry into the 'The Antimicrobial Potential of Bacteriophages'. The MHRA Regulatory Considerations for phage therapeutic products (PTPs) outlines the relevant regulatory route and requirements to use PTPs as licensed or unlicensed medicines. While this guidance provides the necessary information, it is recognized that regulatory information can be inaccessible to academic and small- to medium-sized enterprise developers who are often unfamiliar with the language, terminology and location of such information. The MHRA, in consultation with the Innovate UK Phage Innovation Network, has therefore developed this interpretation to help PTP developers understand what the guidance is saying, and what evidence is required for regulatory assessment of a marketing authorization application. Examples have been included throughout to provide context and as an aid to understanding.

Indexed as

BacteriophagesPhage TherapyDrug ApprovalHumansUnited Kingdomcritical quality attributepersonalized medicinephage therapeutic productsregulation

Identifiers

PMID41230949
PMCPMC12614234

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.