Viruses, Vol. 16, Pages 443: The Medicinal Phage & mdash;Regulatory Roadmap for Phage Therapy under EU Pharmaceutical Legislation

Viruses, Vol. 16, Pages 443: The Medicinal Phage—Regulatory Roadmap for Phage Therapy under EU Pharmaceutical Legislation Viruses doi: 10.3390/v16030443 Authors: Timo Faltus Bacteriophage therapy is a promising approach to treating bacterial infections. Research and development of bacteriophage therapy is intensifying due to the increase in antibiotic resistance and the faltering development of new antibiotics. Bacteriophage therapy uses bacteriophages (phages), i.e., prokaryotic viruses, to specifically target and kill pathogenic bacteria. The legal handling of this type of therapy raises several questions. These include whether phage therapeutics belong to a specially regulated class of medicinal products, and which legal framework should be followed with regard to the various technical ways in which phage therapeutics can be manufactured and administered. The article shows to which class of medicinal products phage therapeutics from wild type phages and from genetically modified (designer) phages do or do not belong. Furthermore, the article explains which legal framework is relevant for the manufacture and administration of phage therapeutics, which are manufactured in advance in a uniform, patient-independent manner, and for tailor-made patient-specific phage therapeutics. For the systematically coherent, successful translation of phage therapy, the article considers pharmaceutical law and related legal areas, such as genetic engineering law. Finally, t...
Source: Viruses - Category: Virology Authors: Tags: Article Source Type: research