clinvestКачественная клиническая практикаKachestvennaya Klinicheskaya Praktika = Good Clinical Practice2588-05192618-8473ООО «Издательство ОКИ10.37489/2588-0519-GCP-0024TGGOBQclinvest-860Research ArticleФАРМАКОНАДЗОРPHARMACOVILIGANCEСтратегии управления рисками лекарственных препаратов: современные международные тенденции и регуляторные решенияRisk management strategies for medicinal products: current international trends and regulatory decisionshttps://orcid.org/0000-0002-8519-2181ЛуцевичК. А.LutsevichK. A.

Луцевич Константин Александрович — к. м. н., доцент

Саратов

Konstantin A. Lutsevich — Cand. Sci. (Med), Associate Professor

Saratov

lutsevich78@mail.ruhttps://orcid.org/0000-0003-3107-7636РешетькоО. В.ReshetkoO. V.

Решетько Ольга Вилоровна  — д. м. н., профессор, зав. кафедрой фармакологии

Саратов

Olga V. Reshetko — Dr. Sci. (Med.), Professor, Head of Department of Pharmacology

Saratov

reshetko@yandex.ruhttps://orcid.org/0000-0003-2008-6895ЛуцевичИ. Н.LutsevichI. N.

Луцевич Игорь Николаевич — д. м. н., профессор

Саратов

Igor N. Lutsevich — Dr. Sci. (Med.), Professor

Saratov

lutsevich.a1@mail.ruФГБОУ ВО «Саратовский государственный медицинский университет имени В. И. Разумовского»РоссияV. I. Razumovsky Saratov State Medical UniversityRussian Federation202630052026022540Copyright © Луцевич К.А., Решетько О.В., Луцевич И.Н., 20262026Луцевич К.А., Решетько О.В., Луцевич И.Н.Lutsevich K.A., Reshetko O.V., Lutsevich I.N.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.clinvest.ru/jour/article/view/860Актуальность

Актуальность. К концу 1990-х гг. система фармаконадзора трансформировалась от реактивной модели к проактивному управлению рисками лекарственных препаратов на протяжении всего жизненного цикла. Однако вопросы стандартизации оценки эффективности мер по минимизации риска и адаптации международных подходов в национальных регуляторных системах остаются дискуссионными.

Цель

Цель. Описать современные международные тенденции внедрения стратегий управления рисками фармакотерапии в контексте регуляторной науки и принятия нормативных решений.

Материал и методы

Материал и методы. Проведён анализ публикаций, посвящённых программам минимизации рисков лекарственных средств, за период 2008–2024 гг. Поиск выполнен в базах MEDLINE/PubMed, Google Scholar с использованием ключевых слов: risk management, pharmacovigilance, drug safety, risk assessment, risk minimization measures, safety communications. Отобраны полнотекстовые оригинальные статьи, обзоры и  систематические обзоры на английском языке. Дубликаты, постеры и тезисы конференций исключены. В окончательный обзор включено 59 источников.

Результаты

Результаты. Показано, что ключевыми инструментами упреждающего управления рисками в США являются программы оценки рисков и стратегии смягчения последствий (REMS), а в Европейском союзе — планы управления рисками (EU-RMP) с дополнительными мерами минимизации риска (aRMM). Анализ нормативных документов FDA, EMA, ICH и CIOMS выявил эволюцию требований от добровольных RiskMAP (2005 г.) к юридически обязательным REMS (с 2007 г.) и модульной системе GVP в ЕС (с 2012 г.). Отмечено, что оценка эффективности мер минимизации риска становится активно развивающейся областью регуляторной науки, однако стандартизация отчётности (например, контрольный список RIMES) и методологическая строгость исследований остаются недостаточными.

Заключение

Заключение. Существующая парадигма управления рисками является критически важной для одобрения лекарственных препаратов и их безопасного применения. Без улучшения прозрачности и унификации отчётности возможности извлечения доказательств из прошлого опыта минимизации рисков остаются ограниченными. Необходимо дальнейшее междисциплинарное сотрудничество для совершенствования методов оценки и разработки новых инструментов минимизации рисков с учётом персонализированной медицины и цифровых технологий.

Relevance

Relevance. By the end of the 1990s, the pharmacovigilance system had transformed from a reactive model to proactive risk management of medicines throughout their life cycle. However, issues of standardising the evaluation of risk minimisation measures and adapting international approaches to national regulatory systems remain debatable.

Objective

Objective. To describe current international trends in the implementation of pharmacotherapy risk management strategies in the context of regulatory science and regulatory decision-making.

Material and methods

Material and methods. We analysed publications on risk minimisation programmes for medicinal products published between 2008 and 2024. The search was conducted in MEDLINE/PubMed and Google Scholar using the following keywords: risk management, pharmacovigilance, drug safety, risk assessment, risk minimization measures, safety communications. Full-text original articles, reviews and systematic reviews in English were selected. Duplicates, posters and conference abstracts were excluded. The final review included 59 sources.

Results

Results. The key tools for proactive risk management are Risk Evaluation and Mitigation Strategies (REMS) in the United States and EU Risk Management Plans (EU-RMPs) with additional risk minimisation measures (aRMM) in the European Union. Analysis of FDA, EMA, ICH and CIOMS guidance documents revealed an evolution from voluntary RiskMAPs (2005) to legally binding REMS (since 2007) and the modular GVP system in the EU (since 2012). Assessing the eff ectiveness of risk minimisation measures is becoming an actively developing area of regulatory science; however, standardisation of reporting (e. g., the RIMES checklist) and methodological rigour remain insuffi cient.

Conclusion

Conclusion. The current risk management paradigm is critical for drug approval and safe use. Without improved reporting transparency and harmonisation, opportunities to generate evidence from past risk minimisation eff orts remain limited. Further interdisciplinary collaboration is needed to improve evaluation methods and develop novel risk minimisation tools, taking into account personalised medicine and digital technologies.

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