safetyriskБезопасность и риск фармакотерапииSafety and Risk of Pharmacotherapy2312-78212619-1164Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/2312-7821-2026-14-1-90-100safetyrisk-537Research ArticleГЛАВНАЯ ТЕМА: ЭВОЛЮЦИЯ ФАРМАКОНАДЗОРА: ИНТЕГРАЦИЯ НОВЫХ ИСТОЧНИКОВ ДАННЫХ, ПОПУЛЯЦИОННЫХ ИCСЛЕДОВАНИЙ И ПРЕДИКТИВНЫХ ТЕХНОЛОГИЙMAIN TOPIC: EVOLUTION OF PHARMACOVIGILANCE: INTEGRATING NEW DATA SOURCES, POPULATION STUDIES AND PREDICTIVE TECHNOLOGIESЛечебно-профилактические препараты бактериофагов: эффективность, безопасность, международный опыт регулирования (обзор)Therapeutic and Prophylactic Bacteriophage Preparations: Efficacy, Safety, and International Regulatory Experience (Review)https://orcid.org/0000-0003-0802-4229КазаковР. Е.KazakovR. E.

Казаков Руслан Евгеньевич, канд. биол. наук

Петровский б-р, д. 8, стр. 2, Москва, 127051

Ruslan E. Kazakov, Cand. Sci. (Biol.)

8/2 Petrovsky Blvd, Moscow 127051

 

kazakov@expmed.ruhttps://orcid.org/0000-0002-7163-7119СереброваС. Ю.SerebrovaS. Yu.

Сереброва Светлана Юрьевна, д-р мед. наук, профессор

Петровский б-р, д. 8, стр. 2, Москва, 127051; Трубецкая ул., д. 8, стр. 2, Москва, 119991

Svetlana Yu. Serebrova, Dr. Sci. (Med.), Professor

8/2 Petrovsky Blvd, Moscow 127051; 8/2 Trubetskaya St., Moscow 119991

serebrova@expmed.ruhttps://orcid.org/0000-0003-1972-4386ЕсаковаЕ. Ю.EsakovaE. Yu.

Есакова Елена Юрьевна, канд. фарм. наук

Петровский б-р, д. 8, стр. 2, Москва, 127051; Трубецкая ул., д. 8, стр. 2, Москва, 119991

Elena Yu. Esakova, Cand. Sci. (Pharm.)

8/2 Petrovsky Blvd, Moscow 127051; 8/2 Trubetskaya St., Moscow 119991

Demchenkova@mail.ruhttps://orcid.org/0000-0002-9198-8661ЖуравлеваМ. В.ZhuravlevaM. V.

Журавлева Марина Владимировна, д-р мед. наук, профессор

Петровский б-р, д. 8, стр. 2, Москва, 127051; Трубецкая ул., д. 8, стр. 2, Москва, 119991

Marina V. Zhuravleva, Dr. Sci. (Med.), Professor

8/2 Petrovsky Blvd, Moscow 127051; 8/2 Trubetskaya St., Moscow 119991

zhuravleva@expmed.ruhttps://orcid.org/0000-0001-7024-5546ПрокофьевА. Б.ProkofievA. B.

Прокофьев Алексей Борисович, д-р мед. наук, профессор

Петровский б-р, д. 8, стр. 2, Москва, 127051; Трубецкая ул., д. 8, стр. 2, Москва, 119991

Alexey B. Prokofiev, Dr. Sci. (Med.), Professor

8/2 Petrovsky Blvd, Moscow 127051; 8/2 Trubetskaya St., Moscow 119991

prokofiev@expmed.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian FederationФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации; Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет им. И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)РоссияScientific Centre for Expert Evaluation of Medicinal Products; I.M. Sechenov First Moscow State Medical University (Sechenov University)Russian Federation20263103202614190100Copyright © Казаков Р.Е., Сереброва С.Ю., Есакова Е.Ю., Журавлева М.В., Прокофьев А.Б., 20262026Казаков Р.Е., Сереброва С.Ю., Есакова Е.Ю., Журавлева М.В., Прокофьев А.Б.Kazakov R.E., Serebrova S.Y., Esakova E.Y., Zhuravleva M.V., Prokofiev A.B.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.risksafety.ru/jour/article/view/537ВВЕДЕНИЕ

ВВЕДЕНИЕ. Препараты бактериофагов эффективны при бактериальных инфекциях, в том числе вызванных возбудителями с множественной лекарственной устойчивостью. Для разработки и широкого использования стандартизованных и персонализированных препаратов для фаготерапии необходима актуализация нормативных правовых и методических документов, регламентирующих разработку, проведение клинических исследований, регистрацию и обращение препаратов бактериофагов.

ЦЕЛЬ

ЦЕЛЬ. Анализ мировых тенденций в области разработки, регистрации, оценки эффективности и безопасности препаратов бактериофагов для определения перспективных направлений развития фаготерапии в Российской Федерации.

ОБСУЖДЕНИЕ

ОБСУЖДЕНИЕ. Несмотря на доказанную эффективность бактериофагов, их широкое внедрение в клиническую практику затрудняют быстрое развитие резистентности у возбудителей инфекций, сложности доставки к очагу инфекции, а также недостаточная изученность безопасности фаготерапии. При снижении эффективности стандартизованных препаратов бактериофагов может потребоваться изменение рецептуры для актуализации штаммов, однако регуляторные механизмы для этого отсутствуют. В Российской Федерации зарегистрированы и применяются 14 стандартизованных препаратов бактериофагов, проведены их клинические исследования. В меньшей степени развито персонализированное применение бактериофагов. В США и государствах – членах Европейского союза, предъявляющих строгие требования к доказательствам безопасности и эффективности лекарственной терапии, фаготерапия не является официальным методом лечения и применяется лишь в отдельных случаях. В некоторых европейских странах, в частности, в Польше и Бельгии, фаготерапии уделяется большое внимание, но применение бактериофагов остается индивидуальным. В 2025 г. в Европейском союзе подготовлена рабочая версия концептуального документа по разработке и производству препаратов на основе бактериофагов для применения у человека. Но до сих пор ни один препарат для фаговой терапии не получил одобрения в соответствии с законодательствами Европейского союза и США.

ВЫВОДЫ

ВЫВОДЫ. Россия имеет уникальный опыт применения стандартизованных фаговых препаратов. При этом регуляторные механизмы внесения изменений в состав уже зарегистрированных препаратов бактериофагов не разработаны ни в России, ни в других странах. Для глобального развития направления необходима международная гармонизация нормативной базы с учетом новых инициатив Европейского союза и США по созданию регуляторных документов, а также интенсификация исследований по преодолению резистентности бактерий к бактериофагам и изучение их долгосрочной безопасности.

INTRODUCTION

INTRODUCTION. Bacteriophage preparations are effective in bacterial infections, including multi-drug resistant pathogens. In order to develop and widely use standardized and personalized phage therapy, current regulations and guidelines governing the development, clinical trials, registration, and distribution of bacteriophage preparations necessitate an update.

AIM

AIM. This study aimed to analyze global trends in the development, registration, as well as efficacy and safety assessment of bacteriophage preparations to identify promising areas for development of phage therapy in the Russian Federation.

DISCUSSION

DISCUSSION. Despite the proven efficacy, rapidly expanding resistance of pathogens, complicated delivery to the infection focal point, and poorly understood safety of phage therapy prevent wide implementation of bacteriophages in clinical practice. In case standardized bacteriophage preparations show decreased effectiveness, a modified formulation may be warranted, with the updated strains; however, no appropriate legislative mechanisms exist so far. To date, 14 standardized bacteriophage preparations were registered and used in the Russian Federation, with completed clinical trials. Personalized phage therapy is used to a lesser extent. In the United States and the European Union (EU) member states, strict requirements for safety and efficacy evidence are placed; phage therapy is not an official treatment method but is used in individual cases. In some countries, particularly Poland and Belgium, phage therapy is under close supervision, while the use of bacteriophages remains individualized. In 2025, a draft of a concept document stipulating development and production of bacteriophage agents for human use was developed in the EU. However, none of the drugs for phage therapy was approved according to the EU and US requirements.

CONCLUSIONS

CONCLUSIONS. Russian Federation has a unique experience of using standardized phage preparations. Regulatory algorithms of modifying the formulation of a registered bacteriophage preparation are still to be developed both in the Russian Federation and other countries. Worldwide harmonization of the regulatory base is an essential element of global development; points to consider include new EU and US initiatives on developing regulatory documents, intensified research aimed at overcoming bacterial resistance to bacteriophages, and long-term safety studies.

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The authors declare that there are no conflicts of interest present.