Microbiome Therapies as an Emerging Therapeutic Approaches of Biomedicine: International Regulatory Approaches and Ethical Challenges

Background: Microbiome-oriented therapies, including fecal microbiota transplantation (FMT), phage therapy, and live biotherapeutic products (LBPs), represent a promising direction in modern biomedicine for addressing antimicrobial resistance (AMR), recurrent Clostridioides difficile infection (rCDI), and dysbiosis-associated conditions. Despite encouraging clinical outcomes, their integration into routine clinical practice remains limited due to regulatory heterogeneity and unresolved ethical challenges. Objective: This review aims to analyze international regulatory approaches to microbiome-based therapies and to identify key bioethical issues associated with their clinical application. Main content: The paper summarizes current scientific evidence and regulatory frameworks governing microbiome therapies in the United States, the European Union, Ukraine, and selected Asia-Pacific countries. Particular attention is given to differences in classification, approval pathways, and safety requirements. The review also examines major ethical concerns, including informed consent, donor screening, biosafety, data protection, and equitable access to innovative treatments. Conclusions: The analysis demonstrates that microbiome therapies have significant potential for improving clinical outcomes and supporting antimicrobial stewardship. However, their broader implementation requires the harmonization of regulatory frameworks, strengthening of biosafety standards, and development of clear ethical guidelines. International cooperation and accumulation of clinical evidence are essential for the safe and effective integration of microbiome-based interventions into healthcare systems.