EMA invites comments on new quality guideline for bacteriophage‑based medicines to support safe phage therapy development in Europe.

EMA public consultation on phage therapy medicinal products

European Medicines Agency (EMA)

The European Medicines Agency (EMA) has opened a public consultation on a draft guideline on the quality aspects of phage therapy medicinal products.

Antibiotic resistance is a serious and growing public health problem worldwide, contributing to morbidity and mortality and increasing the burden on health systems and society. In this context, interest in the use of bacteriophages (phages) to treat infections has increased among both healthcare providers and the pharmaceutical industry.

Bacteriophages are viruses that exclusively infect bacteria, replicate within them and often cause lysis of the bacterial cells when new phage particles are released. Phage therapy refers to the use of phages for the treatment of bacterial infections or infectious diseases, or for the eradication of specific bacteria.

The aim of the draft guideline is to clarify regulatory expectations for quality documentation on bacteriophage active substances and finished products for human use within marketing authorisation applications. It addresses specific aspects of manufacture, control of materials, characterisation, specifications, analytical control, reference standards and stability of bacteriophage active substances. In addition, it provides guidance on the pharmaceutical development, manufacture, control and stability of the finished product.

Stakeholders can provide feedback via the EMA consultation page: Quality aspects of phage therapy medicinal products – public consultation.

News & Updates

You might also be interested in

Radka Kaneva and Petia Stratieva, Sofia, March 2026

“National Mirror Groups are essentially a bridge — bringing European developments, standards and opportunities to clinicians and researchers.”

ERDERA interviews Prof. Radka Kaneva and Dr Petia Stratieva, two leading members of Bulgaria’s National Mirror Group (NMG), to explore how the country is working to align its rare disease ecosystem with European developments.
Gdańsk - Medical University of Gdańsk

From Hyderabad to Gdansk: collaborative diagnostic efforts that bridge research and clinical practice to shorten patients’ path to answers

ERDERA joins the Wilhelm Foundation and the Gdansk Medical University and Clinical Centre to strengthen phenotype‑led diagnosis for people living with undiagnosed conditions
European Parliament

European Parliament draft report urges a binding EU rare disease action framework

A legislative own initiative file in the Parliament’s new public health committee sets out what an EU “rare disease action framework” could look like — and why it could change how Europe measures progress for patients.
European Parliament Photograph

New European Parliament study maps options for an EU rare disease action plan

European Parliament research service assessment, published in February 2026, identifies 31 measures that could form an EU rare disease action plan, highlighting European Reference Networks and cross-border collaboration including ERDERA as drivers of EU added value.

ERDERA's

search form