Regulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections - Policy and Practice Reviews

Sep 28, 2026

Regulatory and development considerations are summarized for creating pre-defined phage therapy medicinal products (PTMPs) to treat antimicrobial resistant bacterial infections. 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 Japan.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages12

Reading Time30 min

AccessFree to download

1 Introduction

Background on antimicrobial resistance

Overview of phage therapy PTMP development in Japan

TYPE Policy and Practice Reviews PUBLISHED 18 December 2025 DOI 10.3389/fphar.2025.1713471 OPEN ACCESS EDITED BY Wangxue Chen, National Research Council Canada (NRC), Canada REVIEWED BY Georgia Mitropooulou, Centre Hospitalier Universitaire Vaudois (CHUV), Switzerland Rajal Dave, Independent researcher, Pune, India *CORRESPONDENCE Ai Fukaya-Shiba, [fukaya-ai@pmda.go.jp](fukaya-ai@pmda.go.jp) †These authors share last authorship RECEIVED 26 September 2025 REVISED 12 November 2025 ACCEPTED 30 November 2025 PUBLISHED 18 December 2025 CITATION Fukaya-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) Regulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections. Front. Pharmacol. 16:1713471 . doi: 10.3389/fphar.2025.1713471 COPYRIGHT © 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. Regulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections Ai Fukaya-Shiba 1*, Akiko Ogata 1, Ryosuke Kuribayashi 2,3, Akira Sakurai 2, Kanako Suzuki 1, Shunsuke Takadama 4, Jihei Nishimura 4, Jumpei Uchiyama 5, Hiroki Ohge 6, Takamasa Takeuchi 7, Hideyuki Tamaki 8, Tetsuya Matsumoto 9, Kotaro Kiga 10† and Hidetomo Iwano 11† 1Ofﬁce 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 Recently, 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,

FAQs

What are the main regulatory areas covered for developing PTMPs?

The document addresses quality control strategies, manufacturing method establishment, non-clinical evaluations, and clinical trial planning based on phage characteristics.

How does the document connect PTMP development to regulatory consultations in Japan?

It summarizes considerations derived from opinions exchanged by the Pharmaceuticals and Medical Devices Agency with external experts from October 2024 to July 2025.

Which regulatory contexts are used to frame the guidance?

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.

Sep 28, 2026

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