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    Academic Journal

    Συνεισφορές: The study reported in this publication was carried out as part of a publicly funded research project No. 056-00023-18-02 and was supported by the FSBI «SCEEMP» of the Ministry of Health of Russia (R&D public accounting No. AAAA-A18-118021590045-2), Работа выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00023-18-02 на проведение прикладных научных исследований (номер государственного учета НИР AAAA-A18-118021590045-2)

    Πηγή: Biological Products. Prevention, Diagnosis, Treatment; Том 18, № 3 (2018); 150-160 ; БИОпрепараты. Профилактика, диагностика, лечение; Том 18, № 3 (2018); 150-160 ; 2619-1156 ; 2221-996X ; 10.30895/2221-996X-2018-18-3

    Περιγραφή αρχείου: application/pdf

    Relation: https://www.biopreparations.ru/jour/article/view/170/140; Распоряжение Правительства Российской Федерации от 28 февраля 2018 г. № 337-р «Об утверждении плана мероприятий («дорожной карты») «Развитие биотехнологий и генной инженерии» на 2018–2020 годы». 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[List of medicinal technologies, authorized for medical practice for December 30, 2011 (In Russ.)] Available from: http://www.roszdravnadzor.ru/archive/documents/12545; Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union. 2007;50(L 324):121–37. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2007_1394/reg_2007_1394_en.pdf; Part 1271 Human cells, tissues, and cellular and tissuebased products (21CFR1271). Code of Federal Regulations Title 21. FDA; 2017.; Tiedemann G, Sethe S. Regulatory framework for cell and tissue based therapies in Europe. In: Steinhoff G, ed. Regenerative medicine — from protocol to patient. 4. Regenerative therapies I. 3rd ed. Switzerland: Springer; 2016. P. 21–33.; Зубов ДА, Васильев РГ, Оксимец ВМ, Родниченко АЕ, Злацкая АВ, Губарь ОС, Гордиенко ИМ. Результаты применения ткане-инженерного эквивалента кости: трехлетний период наблюдений. Материалы III национального конгресса по регенеративной медицине. Гены и Клетки. 2017;XII(3):100–1. [Zubov DA, Vasyliev RG, Oksimets VM, Rodnichenko AE, Zlatskaya AV, Gubar OS, Gordienko IM. The results of the application of tissue-engineering equivalent of the bone: a three-year observation period. Materials of the 3rd national congress on regenerative medicine. Genes and Cells. 2017;XII(3):100–1 (In Russ.)]; Васильев РГ, Грицык ВФ, Литвинова ЛС, Родниченко АЕ, Губарь ОС, Шуплецова ВВ и др. Постнатальные мультипотентные стволовые/прогениторные клетки — производные нервного гребня: трансляция в клиническую практику. Материалы III национального конгресса по регенеративной медицине. Гены и Клетки. 2017;XII(3):59. [Vasyliev RG, Gritsyk VF, Litvinova LS, Rodnichenko AE, Gubar OS, Shupletsova VV, et al. 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Advanced therapies workshop, centre of regulatory excellence, Duke-NUS Medical School, 17–19 July, 2017. Available from: https://teamlead.duke-nus.edu.sg/vapfiles_ocs/core/core_apec_rhsc_coe_adv_therapies_wrkshp_regulate_regenerative_meds_japan/index5.html; Assessment Report. Zalmoxis (EMA/CHMP/589978/2016). EMA; 2016. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002801/WC500212588.pdf; Guideline on the risk-based approach according to annex I,part IV of Directive 2001/83/EC applied to advanced therapy medicinal products (EMA/CAT/CPWP/686637/2011). EMA; 2013.; Concept paper on the revision of the guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells (EMA/CAT/424191/2017). EMA; 2017.; Guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products (EMEA/149995/2008 rev. 1). EMA; 2018.; Ridgway AA. 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Available from: http://law.moj.gov.tw/Eng/LawClass/LawAll.aspx?PCODE=L0020021; Chen YC, Cheng HF, Yeh MK. Cell therapy regulation in Taiwan. Cell Transplant. 2017;26(3):483–92. https://doi.org/10.3727/096368916X693293; 16th ICDRA recommendations. WHO Drug Information. 2014;28(3):298–306. Available from: http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/16_ICDRA_Recommendations2014.pdf; Постановление Совета Министров Республики Беларусь от 28 ноября 2014 г. № 1120 «О некоторых вопросах государственной регистрации биомедицинских клеточных продуктов». [Resolution of the council of ministers of the republic of Belarus of November 28, 2014, No. 1120 «On some issues of State registration of biomedical cell products» (In Russ.)] Available from: http://pravo.by/upload/docs/op/C21401120_1417554000.pdf; https://www.biopreparations.ru/jour/article/view/170

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    Academic Journal

    Relation: Деревянко Б.В. Пропозиції щодо уточнення положень Концепції оновлення Цивільного кодексу України. Правове забезпечення ринкових відносин в умовах громадянського суспільства: зб. наук. праць. Вип. 4. К.: НДІППП імені академіка Ф.Г. Бурчака НАПрН України, 2021. С. 42–47.; http://dspace.puet.edu.ua/handle/123456789/11469

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