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The review reflects consultations by the Pharmaceuticals and Medical Devices Agency between October 2024 and July 2025, incorporating quality control strategies, manufacturing method establishment, non-clinical evaluation approaches, and clinical trial planning aligned with phage characteristics. Guidance is presented based on European and U.S. regulatory trends and includes discussion of the Cartagena Act for PTMP development in 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December 2025 DOI 10.3389/fphar.2025.1713471  \nOPEN ACCESS  \nEDITED BY  \nWangxue Chen,  \nNational Research Council Canada (NRC), Canada  \nREVIEWED BY  \nGeorgia Mitropooulou,  \nCentre Hospitalier Universitaire Vaudois (CHUV), Switzerland  \nRajal Dave,  \nIndependent researcher, Pune, India  \n*CORRESPONDENCE  \nAi Fukaya-Shiba,  \n [fukaya-ai@pmda.go.jp](fukaya-ai@pmda.go.jp)  \n†These authors share last authorship  \nRECEIVED 26 September 2025  \nREVISED 12 November 2025  \nACCEPTED 30 November 2025  \nPUBLISHED 18 December 2025  \nCITATION  \nFukaya-Shiba A, Ogata A, Kuribayashi R, Sakurai A, Suzuki K, Takadama S, Nishimura J, Uchiyama J, Ohge H, Takeuchi T, Tamaki H, Matsumoto T, Kiga K and Iwano H (2025)  \nRegulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections.  \nFront. Pharmacol. 16:1713471 .  \ndoi: 10.3389/fphar.2025.1713471  \nCOPYRIGHT  \n© 2025 Fukaya-Shiba, Ogata, Kuribayashi, Sakurai, Suzuki, Takadama, Nishimura, Uchiyama, Ohge, Takeuchi, Tamaki, Matsumoto, Kiga and Iwano. This is an openaccess article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.  \nRegulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections  \nAi Fukaya-Shiba 1*, Akiko Ogata 1, Ryosuke Kuribayashi 2,3, Akira Sakurai 2, Kanako Suzuki 1, Shunsuke Takadama 4,  \nJihei Nishimura 4, Jumpei Uchiyama 5, Hiroki Ohge 6, Takamasa Takeuchi 7, Hideyuki Tamaki 8, Tetsuya Matsumoto 9, Kotaro Kiga 10† and Hidetomo Iwano 11†  \n1Office of Regulatory Science Coordination, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan, 2Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan, 3Office of Regulatory Science Research, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan, 4Office of New Drug IV, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan, 5Department of Bacteriology, Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan, 6Department of Infectious Diseases, Hiroshima University Hospital, Hiroshima, Japan, 7 Pathogen Genomics Center, National Institute of Infectious Diseases, Japan Institute for Health Security, Tokyo, Japan, 8Biomanufacturing Process Research Center, National Institute of Advanced Industrial Science and Technology, Ibaraki, Japan, 9Department of Infectious Diseases, International University of Health and Welfare, Chiba, Japan, 10Department of Drug Development, National Institute of Infectious Diseases, Japan Institute for Health Security, Tokyo, Japan, 11 Laboratory of Veterinary Biochemistry, Rakuno Gakuen University School of Veterinary Medicine, Hokkaido, Japan  \nRecently, there have been growing expectations that treatment of infections with bacteriophages (phages), viruses which specifically infect bacteria, can be used asa treatment option for antimicrobial resistant bacterial infections. In Europe and the United States, in addition to phage therapy as a form of personalized medicine, development of pre-defined phage therapy medicinal products (PTMPs) is progressing, and clinical trials are underway. From October 2024 to July 2025, the Pharmaceuticals and Medical Devices Agency exchanged opinionson trends and points to consider in drug development of PTMPs used for antimicrobial resistant bacterial infections with external experts. Development of PTMPs for regulatory approval requires quality control strategies, establishment of manufacturing methods, non-clinical evaluations,","cbCaildMWEPS7vMh","https://ap.wps.com/l/cbCaildMWEPS7vMh","pdf",1170234,12,"English","# 1 Introduction\n## Background on antimicrobial resistance\n## Overview of phage therapy PTMP development in Japan","[{\"question\":\"What are the main regulatory areas covered for developing PTMPs?\",\"answer\":\"The document addresses quality control strategies, manufacturing method establishment, non-clinical evaluations, and clinical trial planning based on phage characteristics.\"},{\"question\":\"How does the document connect PTMP development to regulatory consultations in Japan?\",\"answer\":\"It summarizes considerations derived from opinions exchanged by the Pharmaceuticals and Medical Devices Agency with external experts from October 2024 to July 2025.\"},{\"question\":\"Which regulatory contexts are used to frame the guidance?\",\"answer\":\"The review draws on regulatory and development trends in Europe and the United States and summarizes considerations for PTMP development in Japan, including discussion of the Cartagena Act.\"}]","Regulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections - Policy and Practice Reviews | PDF",1790586858]