title: European regulatory conundrum of phage therapy.
abstract: The treatment of infectious diseases with antibiotics is becoming increasingly challenging. Very few new antimicrobials are in the pharmaceutical industry pipeline. One of the potential alternatives for antibiotics is phage therapy. Major obstacles for the clinical application of bacteriophages are a false perception of viruses as 'enemies of life' and the lack of a specific frame for phage therapy in the current Medicinal Product Regulation. Short-term borderline solutions under the responsibility of a Medical Ethical Committee and/or under the umbrella of the Declaration of Helsinki are emerging. As a long-term solution, however, we suggest the creation of a specific section for phage therapy under the Advanced Therapy Medicinal Product Regulation.
authors.affiliation: Hospital Center of the Base-Queen Astrid, Laboratory for Molecular & Cellular Technology, Burn Unit, Bruynstraat 1, B-1120 Neder-over-Heembeek, Belgium. gilbert.verbeken@mil.be
authors.forename: Gilbert
authors.initials: G
authors.lastname: Verbeken
authors.forename: Daniel
authors.initials: D
authors.lastname: De Vos
authors.forename: Mario
authors.initials: M
authors.lastname: Vaneechoutte
authors.forename: Maya
authors.initials: M
authors.lastname: Merabishvili
authors.forename: Martin
authors.initials: M
authors.lastname: Zizi
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Pirnay
mesh_terms: D001419:Bacteria / Q000821:virology*; D001424:Bacterial Infections / Q000628:therapy* / Q000821:virology*; D001435:Bacteriophages / Q000502:physiology*; D001691:Biological Therapy / Q000379:methods / Q000592:standards; D005060:Europe; D033161:Government Regulation; D006801:Humans; D019936:Probiotics