Essential Topics for the Regulatory Consideration of Phages as Clinically Valuable Therapeutic Agents: A Perspective from Spain

Bibliographic Details
Title: Essential Topics for the Regulatory Consideration of Phages as Clinically Valuable Therapeutic Agents: A Perspective from Spain
Authors: Roberto Vázquez, Roberto Díez-Martínez, Pilar Domingo-Calap, Pedro García, Diana Gutiérrez, Maite Muniesa, María Ruiz-Ruigómez, Rafael Sanjuán, María Tomás, María Ángeles Tormo-Mas, Pilar García
Source: Microorganisms, Vol 10, Iss 4, p 717 (2022)
Publisher Information: MDPI AG, 2022.
Publication Year: 2022
Collection: LCC:Biology (General)
Subject Terms: phage therapy, bacteriophages, endolysins, antimicrobial resistance, compassionate use, drug regulation, Biology (General), QH301-705.5
More Details: Antibiotic resistance is one of the major challenges that humankind shall face in the short term. (Bacterio)phage therapy is a valuable therapeutic alternative to antibiotics and, although the concept is almost as old as the discovery of phages, its wide application was hindered in the West by the discovery and development of antibiotics in the mid-twentieth century. However, research on phage therapy is currently experiencing a renaissance due to the antimicrobial resistance problem. Some countries are already adopting new ad hoc regulations to favor the short-term implantation of phage therapy in clinical practice. In this regard, the Phage Therapy Work Group from FAGOMA (Spanish Network of Bacteriophages and Transducing Elements) recently contacted the Spanish Drugs and Medical Devices Agency (AEMPS) to promote the regulation of phage therapy in Spain. As a result, FAGOMA was asked to provide a general view on key issues regarding phage therapy legislation. This review comes as the culmination of the FAGOMA initiative and aims at appropriately informing the regulatory debate on phage therapy.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2076-2607
Relation: https://www.mdpi.com/2076-2607/10/4/717; https://doaj.org/toc/2076-2607
DOI: 10.3390/microorganisms10040717
Access URL: https://doaj.org/article/f7a84f1a4988449b94d6a456f22c9ca8
Accession Number: edsdoj.f7a84f1a4988449b94d6a456f22c9ca8
Database: Directory of Open Access Journals
More Details
ISSN:20762607
DOI:10.3390/microorganisms10040717
Published in:Microorganisms
Language:English