Currently, antibiotic resistance has become a serious problem worldwide contributing to morbidity and mortality and increasing the burden for society and hospitalisation costs. This is the reason why there is an increasing interest in the use of phages for the treatment of infections or infectious diseases both from the healthcare providers and pharmaceutical industry.

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

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

If you want to provide your contribution follow this link: Quality aspects of phage therapy medicinal products | European Medicines Agency (EMA)