vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/1991-2919-2019-9-1-14-27vedomostiregmed-208Research ArticleОБЗОРЫREVIEWSПодходы к клинической разработке комбинированных лекарственных препаратов в Российской Федерации и Евразийском экономическом союзе с учетом требований действующего законодательстваApproaches to clinical development of combination medicines in the Russian Federation and the Eurasian Economic Union in view of the requirements of the current legislationhttps://orcid.org/0000-0002-9476-0515ДобровольскийА. В.DobrovolskiyA. V.

Кандидат медицинских наук, ведущий эксперт Управления №2 по эффективности и безопасности лекарственных средств

Researcher ID : C-8144-2018SPIN-код автора: 8120-1672

Петровский бульвар, д. 8, стр. 2, Москва, 127051, Российская Федерация

MD, PhD, Leading expert of the Division №2 on Effectiveness and Safety of Medicinal Products; Centre for Evaluation and Control of Medicinal Products of 

Researcher ID : C-8144-2018SPIN-code of author: 8120-1672

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation

Dobrovolsky@expmed.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения»РоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation201920022019911427Copyright © Добровольский А.В., 20192019Добровольский А.В.Dobrovolskiy A.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/208

Интерес к созданию комбинированных лекарственных препаратов (фиксированных комбинаций), содержащих два или более действующих веществ в одной лекарственной форме, в последние годы растет. В связи с этим весьма актуальной является проблема выработки оптимальной программы предрегистрационных клинических исследований комбинированных лекарственных препаратов. Цель работы – представить современные научно обоснованные подходы к клиническому изучению комбинированных лекарственных препаратов и указать возможные способы их практической реализации с учетом требований действующего законодательства. Был выполнен анализ научных публикаций по проблеме создания фиксированных комбинаций лекарственных средств, а также проанализированы нормативно-правовые документы, определяющие регуляторные требования к предрегистрационному клиническому изучению лекарственных препаратов в Евразийском экономическом союзе, Российской Федерации и других странах. На основании проведенного анализа описаны общие регуляторные требования к планированию клинических исследований фиксированных комбинаций в целях их последующей регистрации в Российской Федерации (по национальной процедуре) и в Евразийском экономическом союзе (по централизованной процедуре). Для каждого комбинированного лекарственного препарата программа предрегистрационного клинического изучения должна разрабатываться индивидуально. Выбор оптимальной стратегии клинических исследований позволит получить достаточную информацию об эффективности и безопасности комбинированного лекарственного препарата для его последующей регистрации.

In recent years, there has been an increasing interest in the development of combination medicines (fixed drug combinations) containing two or more active ingredients in a single dosage form. Therefore, there is an urgent need to develop an optimal programme of pre-authorisation clinical trials for combination medicines. The aim of the paper was to summarise modern science-based approaches to clinical development of combination medicines and identify possible ways of their practical implementation, taking into account the requirements of the current legislation. The author reviewed scientific publications devoted to creation of fixed drug combinations and analysed the regulatory documents defining regulatory requirements for pre-authorisation clinical studies of medicines in the Eurasian Economic Union, the Russian Federation, and other countries. Based on the results of the analysis the author described the general regulatory requirements for planning clinical studies of combination medicines for the purpose of their subsequent authorisation in the Russian Federation (via the national procedure) and the Eurasian Economic Union (via the centralized procedure). The pre-authorisation clinical development programme should be designed individually for each combination medicine. The selection of an optimal clinical trial strategy will make it possible to obtain sufficient information on the efficacy and safety of a combination medicine for its subsequent authorisation.

 

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