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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">vedomostiregmed</journal-id><journal-title-group><journal-title xml:lang="ru">Регуляторные исследования и экспертиза лекарственных средств</journal-title><trans-title-group xml:lang="en"><trans-title>Regulatory Research and Medicine Evaluation</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">3034-3062</issn><issn pub-type="epub">3034-3453</issn><publisher><publisher-name>Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">vedomostiregmed-37</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОБЗОРНЫЕ И ПРОБЛЕМНЫЕ СТАТЬИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>GENERAL AND TOPICAL ARTICLES</subject></subj-group></article-categories><title-group><article-title>Международные непатентованные наименования лекарственных средств: требования к формированию заявки и порядок экспертизы и регистрации Всемирной организацией здравоохранения</article-title><trans-title-group xml:lang="en"><trans-title>International nonproprietary names of drugs: requirements for an application and order of examination and registration of the world health organization</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Дудченко</surname><given-names>В. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Dudchenko</surname><given-names>V. V.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Яворский</surname><given-names>А. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Yavorskiy</surname><given-names>A. N.</given-names></name></name-alternatives><email xlink:type="simple">Alexyavorsky@expmed.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Олефир</surname><given-names>Ю. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Olefir</surname><given-names>Yu. V.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Бунятян</surname><given-names>Н. Д.</given-names></name><name name-style="western" xml:lang="en"><surname>Bunyatyan</surname><given-names>N. D.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2015</year></pub-date><pub-date pub-type="epub"><day>13</day><month>02</month><year>2018</year></pub-date><volume>0</volume><issue>2</issue><fpage>29</fpage><lpage>34</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Дудченко В.В., Яворский А.Н., Олефир Ю.В., Бунятян Н.Д., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Дудченко В.В., Яворский А.Н., Олефир Ю.В., Бунятян Н.Д.</copyright-holder><copyright-holder xml:lang="en">Dudchenko V.V., Yavorskiy A.N., Olefir Y.V., Bunyatyan N.D.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.vedomostincesmp.ru/jour/article/view/37">https://www.vedomostincesmp.ru/jour/article/view/37</self-uri><abstract><p>Представлена обобщенная информация о программе Всемирной организации здравоохранения (ВОЗ) по международным непатентованным наименованиям (МНН) лекарственных средств и роли МНН в сфере обращения лекарственных средств. Отражены общие принципы выбора МНН и требования к формированию заявки на получение МНН. Присвоение МНН фармацевтической субстанции является высшим критерием признания международным экспертным сообществом инновационности лекарственного средства, созданного конкретным разработчиком и позволяет объективно судить о вкладе разных стран в глобальную систему охраны здоровья. Актуальным является вопрос функционирования национальной системы экспертного отбора и введения в действие МНН для оригинальных отечественных лекарственных средств.</p></abstract><trans-abstract xml:lang="en"><p>Brief information about the program of the World Health Organization (WHO) for International Nonproprietary Names (INN) for drugs and the role of the INN in the sphere of circulation of medicines is represented. The general principles of INN selection and requirements for development applications for the INN are described. The assignment of an INN of the pharmaceutical substance is the highest criterion for recognition by the international expert community of innovative medicines created by a particular developer and makes it possible to objectively judge the contribution of different countries in global health. Questions of functioning of the national system of the selection and introduction of INN for domestic original pharmaceutical medicines have the high urgency.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>name of the medicinal product</kwd><kwd>the international nonproprietary name</kwd><kwd>rational choice</kwd><kwd>the sphere of circulation of medicines</kwd><kwd>наименование лекарственного средства</kwd><kwd>международное непатентованное наименование</kwd><kwd>рациональный выбор</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Стратегия развития фармацевтической промышленности Российской Федерации на период до 2020 года (Стратегия «Фарма2020»).</mixed-citation><mixed-citation xml:lang="en">The development strategy of the pharmaceutical industry of the Russian Federation for the period until 2020 (Strategy «Farma2020») (in Russian).</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Стратегия лекарственного обеспечения населения Российской Федерации до 2025 года.</mixed-citation><mixed-citation xml:lang="en">The strategy of the drug provision of the population of the Russian Federation until 2025 (in Russian).</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Резолюция WHA 3.11 «Непатентованные наименования ЛС».</mixed-citation><mixed-citation xml:lang="en">Resolution WHA 3.11 «Nonproprietary Names of Medicines» (in Russian).</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Guidelines on use of International Nonproprietary Names (INNs) for Pharmaceutical Substances. 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