Russian MedicineRussian Medicine0869-21062412-9100Eco-Vector3829210.17816/rmj38292Research ArticleThe algorithm of evaluation of interchangeability of pharmaceuticalsRomanovBoris K.MD, PHD, DScRomanov@expmed.ruSakaevaI. V-BunyatyanN. D-VasilyevA. N-BondarevV. P-ProkofyevA. B-YagudinaR. I-AlyautdinR. N-KovalevaE. L-PereversevA. P-ZatolochinaK. E-KazakovA. S-KomratovA. V-KoshechkinK. A-PasternakE. Yu-The research center of expertise of means of medical application of Minzdrav of Russia15102015215434721072020Copyright © 2015, Eco-Vector2015The article presents originally developed algorithm of expertise of interchangeability of pharmaceuticals for medical application. The interchangeable pharmaceutical is a pharmaceutical with evidenced therapeutic equivalence or bioequivalence concerning reference (original) pharmaceutical with equivalent qualitative and quantitative compound of active substances, auxiliary substances, medicinal form, identical way of administration and mode of application and manufactured according requirements of rules of proper processing practice. The interchangeability of pharmaceutical to reference pharmaceutical is established during state registration of pharmaceutical or at introduction of changes into documents contained in registration dossier of already registered pharmaceutical in the Russian Federation. The application about establishment of interchangeability by applicant - holder or owner of registration certification of pharmaceutical for medical application is required.interchangeabilitypharmaceuticalbioequivalencetherapeutic equivalencealgorithmexpertiseвзаимозаменяемостьлекарственное средствобиоэквивалентностьтерапевтическая эквивалентностьалгоритмэкспертиза[Федеральный закон от 22.12.2014 № 429-ФЗ «О внесении изменений в Федеральный закон "Об обращении лекарственных средств"». М.; 2014.][Сводный отчет о проведении оценки регулирующего воздействия (Цит. по http://regulation.gov.ru/project/22466.html, дата обращения - 12.01.2015).][Федеральный закон от 12.04.2010 № 61-ФЗ (ред. от 22.10.2014) "Об обращении лекарственных средств" (с изм. и доп.). М.; 2014.][Лепахин В.К., Романов Б.К., Никитина Т.Н., Снегирева И.И. Экспертиза оценки отношения ожидаемой пользы к возможному риску применения лекарственых средств. Ведомости Научного центра экспертизы средств медицинского применения. 2012; 2: 19-21.][Truus Janse-de Hoog. Interchangeability of generics. European Medicines Agency. URL:http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2011/06/WC500107873.pdf. (Accessed 12 January 2015).][Approved Drug Products with Therapeutic Equivalence Evaluations, 34nd (2014) [Orange Book]. United States Food and Drug Administration / URL: http://www.accessdata.fda.gov/scripts/cder/ob. (Accessed 12 January 2015).][Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009 (Draft Guidance Updated for 508 on 3/22/12). Food and Drug Administration. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatory Information/Guidances/ucm259797.htm. (Accessed 12 January 2015).]