The European Medicines Agency (EMA) has opened a public consultation on a “concept paper on the development and manufacture guidelines for human medicinal products tailored to phage therapy.” This initiative aims to establish a scientific framework for the pharmaceutical development and manufacturing of bacteriophage medicinal products, specifically for treating or preventing bacterial infections in humans.
While guidelines for veterinary bacteriophage medicinal products exist, the absence of regulatory guidance for human medicinal products in the EU necessitates this proposal. With antibiotic-resistant bacteria on the rise, posing severe threats like pneumonia, urinary tract infections, and bloodstream infections, there is an urgent need for effective treatments.
Antimicrobial resistance is a global concern, contributing significantly to morbidity, mortality, and escalating hospitalization costs. Bacteriophages offer a promising alternative to conventional antibiotics, particularly for infections unresponsive to traditional treatments. Consequently, there’s growing interest in phage therapy from healthcare providers and the pharmaceutical industry alike.
Stakeholders and interested parties are encouraged to provide comments by March 31, 2024, using the EU survey form. Please note that the EMA may collect and process personal data from contributors to the consultation.
Read more here.
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