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.