Comparative analysis of regulatory frameworks in different countries regarding the production of bacteriophage preparations

Abstract

The rise of antimicrobial resistance is one of the major global challenges in modern medicine and veterinary practice, necessitating the search for alternative or complementary antimicrobial approaches. Bacteriophages, as viruses that selectively infect bacteria, are considered promising agents for the prevention and treatment of bacterial infections, particularly those caused by antibiotic-resistant pathogens. Despite their significant therapeutic potential, the widespread implementation of phage-based products in clinical and veterinary practice is substantially limited by the lack of unified and clearly defined regulatory mechanisms governing their production, quality control, and use. The aim of this study was to conduct a comparative analysis of the regulatory frameworks governing the manufacture and circulation of bacteriophage products in the European Union, the United States of America, and Ukraine, with a focus on identifying regulatory gaps and determining prospects for the development of legislation in the field of veterinary medicine. The study analyzed current legislative acts, regulatory authority guidelines, pharmacopoeial requirements, and contemporary scientific publications related to phage therapy and the biotechnological production of phage preparations. The results demonstrate that in all reviewed jurisdictions bacteriophages are regulated as biological medicinal products; however, approaches to their legal classification, good manufacturing practice requirements, pharmacopoeial standardization, and clinical evaluation differ significantly. In the European Union, wild-type bacteriophages are considered conventional medicinal products, whereas genetically modified phages may fall under the regulatory framework for advanced therapy medicinal products. In the United States, phage products are subject to centralized regulation as biological medicinal products, with the possibility of individualized use in exceptional clinical cases. In Ukraine, specialized regulatory provisions, pharmacopoeial standards, and distinct regulatory approaches for bacteriophage products are currently lacking. The findings highlight the need for the development and harmonization of national legislation based on international experience to ensure the quality, safety, and efficacy of bacteriophage products and to establish a legal framework for their implementation in veterinary practice.