Development and manufacture of human medicinal products specifically designed for phage therapy - Scientific guideline

This concept paper proposes to establish a scientific guideline for the pharmaceutical development and manufacture of bacteriophage medicinal products intended for the therapeutic treatment or prophylaxis of one or more specific bacterial infection(s) or infectious disease(s) in humans. Although an EMA guideline for such products exists for veterinary medicinal products, there is currently no appropriate regulatory guidance for medicinal products for human use in the EU. The number of bacteria resistant to antibiotic treatment is dramatically increasing, and these cause life threatening infections such as pneumonia, urinary tract infections, bloodstream infections, wound infections, infections in cystic fibrosis and medical-device related infections. Antimicrobial resistance has become a serious problem worldwide contributing to morbidity and mortality, and increasing the burden for society and hospitalisation costs.  Bacteriophages are a promising alternative to antibiotics for the treatment of infections that do not respond to conventional treatment options. There is an increasing interest in the use of bacteriophages for the treatment of infections both from the healthcare providers and pharmaceutical industry.

Keywords: Guideline, Bacteriophage, Phage Therapy, Development and Manufacture, Active Substance, Finished Product, Antimicrobial Resistance

Current version

Concept paper on the establishment of a Guideline on the development and manufacture of human medicinal products specifically designed for phage therapy

Consultation dates: 22/12/2023 to 31/03/2024Draft: consultation openReference Number: EMA/CHMP/BWP/486838/2023Summary:

This concept paper proposes to establish a scientific guideline for the pharmaceutical development and manufacture of bacteriophage medicinal products intended for the therapeutic treatment or prophylaxis of one or more specific bacterial infection(s) or infectious disease(s) in humans. Although an EMA guideline for such products exists for veterinary medicinal products, there is currently no appropriate regulatory guidance for medicinal products for human use in the EU. The number of bacteria resistant to antibiotic treatment is dramatically increasing, and these cause life threatening infections such as pneumonia, urinary tract infections, bloodstream infections, wound infections, infections in cystic fibrosis and medical-device related infections. Antimicrobial resistance has become a serious problem worldwide contributing to morbidity and mortality, and increasing the burden for society and hospitalisation costs.  Bacteriophages are a promising alternative to antibiotics for the treatment of infections that do not respond to conventional treatment options. There is an increasing interest in the use of bacteriophages for the treatment of infections both from the healthcare providers and pharmaceutical industry.

Keywords: Guideline, Bacteriophage, Phage Therapy, Development and Manufacture, Active Substance, Finished Product, Antimicrobial Resistance