RT Generic
T1 Essential Topics for the Regulatory Consideration of Phages as Clinically Valuable Therapeutic Agents: A Perspective from Spain
A1 Vazquez, Roberto
A1 Diez-Martinez, Roberto
A1 Domingo-Calap, Pilar
A1 Garcia, Pedro
A1 Gutierrez, Diana
A1 Muniesa, Maite
A1 Ruiz-Ruigomez, Maria
A1 Sanjuan, Rafael
A1 Tomas, Maria
A1 Angeles Tormo-Mas, Maria
A1 Garcia, Pilar
K1 phage therapy
K1 bacteriophages
K1 endolysins
K1 antimicrobial resistance
K1 compassionate use
K1 drug regulation
K1 Resistant staphylococcus-aureus
K1 Pseudomonas-aeruginosa
K1 Bacteriophage therapy
K1 Cystic-fibrosis
K1 Stabilization
K1 Purification
K1 Combination
K1 Formulation
K1 Volunteers
K1 Infection
AB 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.
PB Mdpi
YR 2022
FD 2022-04-01
LK http://hdl.handle.net/10668/21433
UL http://hdl.handle.net/10668/21433
LA en
DS RISalud
RD Apr 10, 2025