title: Bacteriophage therapy: a regulatory perspective.
abstract: Despite the recognized problem of antibiotic multidrug resistance, very few antibacterial agents with new mechanisms of action are under development. Bacteriophage therapy could offer one alternative strategy to mitigate this challenge. Although widely used throughout the 20th century in Eastern Europe and the former Soviet Union, this potential therapy has not yet been investigated according to rigorous scientific standards. This paper reports on a multistakeholder meeting held at the EMA, which outlined the existing regulatory framework to which such therapy should adhere and reviewed the current obstacles and shortcomings in scientific development for bacteriophage therapy.
authors.affiliation: Office of Anti-infectives and Vaccines, Human Medicines Evaluation Division, European Medicines Agency, London, UK eric.pelfrene@ema.europa.eu.
authors.forename: Eric
authors.initials: E
authors.lastname: Pelfrene
authors.affiliation: Office of Anti-infectives and Vaccines, Human Medicines Evaluation Division, European Medicines Agency, London, UK.
authors.forename: Elsa
authors.initials: E
authors.lastname: Willebrand
authors.affiliation: Quality Office, Human Medicines Evaluation Division, European Medicines Agency, London, UK.
authors.forename: Ana
authors.initials: A
authors.lastname: Cavaleiro Sanches
authors.affiliation: Regulatory Affairs Office, Human Medicines Research and Development Support Division, European Medicines Agency, London, UK.
authors.forename: Zigmars
authors.initials: Z
authors.lastname: Sebris
authors.affiliation: Office of Anti-infectives and Vaccines, Human Medicines Evaluation Division, European Medicines Agency, London, UK.
authors.forename: Marco
authors.initials: M
authors.lastname: Cavaleri
mesh_terms: D001424:Bacterial Infections / Q000628:therapy*; D017277:Drug Approval; D005060:Europe; D006801:Humans; D000071059:Phage Therapy / Q000379:methods* / Q000592:standards*