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’)10.30895/1991-2919-2022-12-4-379-388vedomostiregmed-501Research ArticleРЕГУЛИРОВАНИЕ ОБРАЩЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВREGULATION OF MEDICINESРегулирование обращения радиофармацевтических препаратовRegulation of Radiopharmaceutical Productshttps://orcid.org/0000-0001-8353-7863КосенкоВ. В.KosenkoV. V.

Косенко Валентина Владимировна, канд. фарм. наук

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

Valentina V. Kosenko, Cand. Sci. (Pharm.)

127051, Moscow, Petrovsky Blvd, 8/2

Kosenko@expmed.ruhttps://orcid.org/0000-0003-4628-5139ТрапковаА. А.TrapkovaA. A.

Трапкова Алла Аркадьевна, канд. биол. наук

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

Alla A. Trapkova, Cand. Sci. (Biol.)

127051, Moscow, Petrovsky Blvd, 8/2

trapkova@expmed.ruhttps://orcid.org/0000-0002-2396-4561КалмыковС. Н.KalmykovS. N.

Калмыков Степан Николаевич, д-р хим. наук, профессор, академик РАН

119991, Москва, Ленинские горы, д. 1, стр. 3

Stepan N. Kalmykov, Dr. Sci. (Chem), Professor, Academician of the Russian Academy of Sciences

119991, Moscow, Leninskie Gory, 1/3

stepan@radio.chem.msu.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian FederationФедеральное государственное бюджетное образовательное учреждение высшего образования «Московский государственный университет имени М. В. Ломоносова»РоссияLomonosov Moscow State UniversityRussian Federation202203112022124379388Copyright © Косенко В.В., Трапкова А.А., Калмыков С.Н., 20222022Косенко В.В., Трапкова А.А., Калмыков С.Н.Kosenko V.V., Trapkova A.A., Kalmykov S.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.vedomostincesmp.ru/jour/article/view/501

Бурное развитие радиоизотопных методов диагностической и терапевтической медицины привело к необходимости совершенствования соответствующего законодательного регулирования обращения радиофармацевтических лекарственных препаратов. В обзоре рассматриваются вопросы классификации радиофармацевтических препаратов в зависимости от технологии их получения, свойств радионуклида и применения в медицине; действующие в настоящее время законодательные и нормативные требования к радиофармацевтическим лекарственным препаратам, а также пути развития регулирования обращения данного вида лекарственных препаратов в рамках национального законодательства и законодательства Евразийской экономической комиссии.

The fast development of diagnostic and therapeutic radionuclide technologies requires enhanced legislative regulation of radiopharmaceuticals. The article addresses the challenge of classifying radiopharmaceuticals depending on the manufacturing technology, radionuclide properties, and clinical use. The review covers the current legislative and regulatory requirements for radiopharmaceutical medicinal products. It also describes the trends in radiopharmaceutical regulation development in Russia and the Eurasian Economic Union, taking into account the corresponding legislative frameworks.

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