pharmjournalРазработка и регистрация лекарственных средствDrug development & registration2305-20662658-5049LLC «CPHA»10.33380/2305-2066-2026-15-2-2191pharmjournal-2321Research ArticleДОКЛИНИЧЕСКИЕ И КЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯPRECLINICAL AND CLINICAL STUDIESЭволюция клинических исследований: комплексный анализ ICH E6(R3) и интегрированных систем управления качеством в клинических исследованиях в фармацевтической отраслиEvolution of clinical trials: a comprehensive analysis of ICH E6(R3) and integrated quality management systems in the pharmaceutical industryhttps://orcid.org/0009-0009-8195-452XКамхаМ. М.KamkhaM. M.

119991, г. Москва, Ленинские горы, д. 1

1, Leninskie Gory, Moscow, 119991

Mikhail.kamkha@yandex.ruhttps://orcid.org/0009-0002-4553-8616МаргаеваБ. Ю.MargaevaB. Y.

119991, г. Москва, Ленинские горы, д. 1

1, Leninskie Gory, Moscow, 119991

https://orcid.org/0009-0009-0463-1110БабичеваН. А.BabichevaN. A.

119991, г. Москва, Ленинские горы, д. 1

1, Leninskie Gory, Moscow, 119991

https://orcid.org/0009-0004-6417-1105УльяноваС. Е.UlyanovaS. E.

119991, г. Москва, Ленинские горы, д. 1

1, Leninskie Gory, Moscow, 119991

Федеральное государственное бюджетное образовательное учреждение высшего образования «Московский государственный университет имени М. В. Ломоносова» (МГУ имени М. В. Ломоносова)Lomonosov Moscow State University202611062026152112124Copyright © Камха М.М., Маргаева Б.Ю., Бабичева Н.А., Ульянова С.Е., 20262026Камха М.М., Маргаева Б.Ю., Бабичева Н.А., Ульянова С.Е.Kamkha M.M., Margaeva B.Y., Babicheva N.A., Ulyanova S.E.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmjournal.ru/jour/article/view/2321Введение

Введение. В условиях цифровой трансформации и глобальной гармонизации регуляторных требований актуальным становится внедрение интегрированных систем управления качеством в клинических исследованиях на основе ICH E6(R3).

Цель

Цель. Провести сравнительный анализ ICH E6(R3) с международными стандартами (ISO, GAMP 5, PMBOK/APM-BOK) и оценить возможности их адаптации в российской регуляторной среде.

Материалы и методы

Материалы и методы. Выполнен систематический анализ нормативно-правовой базы РФ (Федеральный закон РФ № 61 от 12 апреля 2010 г., решение Совета ЕЭК 79 «Об утверждении Правил надлежащей клинической практики Евразийского экономического союза» от 03 ноября 2016, ГОСТ Р 52379-2005 «Надлежащая клиническая практика») и международных руководств (ICH, ISO, EMA, PMI, ISPE), а также научных публикаций за 2020–2025 гг. из Scopus и Web of Science.

Результаты и обсуждение

Результаты и обсуждение. Установлено, что ICH E6(R3) требует перехода от реактивного контроля к проактивному управлению качеством через интеграцию рискориентированных подходов, цифровых технологий и междисциплинарных стандартов. В российском контексте выявлены пробелы в нормативном регулировании и недостаточная интеграция систем менеджмента качества.

Заключение

Заключение. Для соответствия ICH E6(R3) российским регуляторным органам и организациям необходимо модернизировать внутренние процессы, внедрять RBQM (рискориентированный подход к качеству) и гармонизировать национальные требования с международными стандартами.

Introduction

Introduction. In the context of digital transformation and global harmonization of regulatory requirements, the implementation of integrated quality management systems in clinical trials based on ICH E6(R3) has become increasingly relevant.

Aim

Aim. To conduct a comparative analysis of ICH E6(R3) against international standards (ISO, GAMP 5, PMBOK/APM-BOK) and assess their adaptability within the Russian regulatory environment.

Materials and methods

Materials and methods. A systematic analysis was performed of the Russian regulatory framework – including Federal Law No. 61-FZ of April 12, 2010; Decision No. 79 of the Eurasian Economic Commission Council of November 3, 2016, approving the Good Clinical Practice Rules of the Eurasian Economic Union; and GOST R 52379-2005 "Good Clinical Practice" – as well as international guidelines (ICH, ISO, EMA, PMI, ISPE) and scientific publications from 2020 to 2025 indexed in Scopus and Web of Science.

Results and discussion

Results and discussion. It was established that ICH E6(R3) necessitates a shift from reactive oversight to proactive quality management through the integration of risk-based approaches, digital technologies, and interdisciplinary standards. Within the Russian context, gaps in regulatory provisions and insufficient integration of quality management systems were identified.

Conclusion

Conclusion. To align with ICH E6(R3), Russian regulatory authorities and organizations must modernize internal processes, implement Risk-Based Quality Management (RBQM), and harmonize national requirements with international standards.

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