The approaches of the European Union to the regulation of cell therapy.


	Law and Politics Reference: Salagay, O.O. The approaches of the European Union to the regulation of cell therapy. // Law and Politics. 2012. № 8. P. 1357-1363. URL: https://en.nbpublish.com/library_read_article.php?id=51810 Salagay, O.O. The approaches of the European Union to the regulation of cell therapy. Abstract: Since the achievements of the cell biology are novel for all of the legal systems of the states in the world, the analysis of the foreign experience of its regulation are of much practical and theoretical interest. The experience of the EU is especially valuable, since the EU is one of the leaders in the sphere of development of cell therapy, and it possesses quite a specifi c legal system. This article is devoted to the analysis of the EU experience in this sphere. The author analyzes topical community legislation, which regulates the procedure of access of advanced medications into the market, specifi c features of classifi cation of such products and requirements to them. Based on the analysis, the author comes to the conclusion on the need to optimize the legal regulation in this sphere in the Russian Federation. Keywords: jurisprudence, cells, tissues, bio-security, effi ciency, the European Union, studies, research, treatment, bio-materials, technologies. This article can be downloaded freely in PDF format for reading. Download article References 1. Anisimov S.V. Kletochnaya terapiya bolezni Parkinsona: II. Primenenie somaticheskikh stvolovykh kletok. Uspekhi 2. Gerontologii. 2009. 22. №1. S.150-166. 3. Vasil'ev A.V. i soavt. Pravovye aspekty nauchnykh issledovaniy v oblasti razvitiya kletochnykh tekhnologiy i 4. vnedreniya ikh v klinicheskuyu praktiku. Meditsinskoe pravo. 2010. №3. S. 9-14. 5. Kontsevenko A.S. Pravovoe regulirovanie biomeditsinskikh issledovaniy i primeneniya novykh biotekhnologiy 6. v Evropeyskom Soyuze: Dis. … kand. yurid. nauk. M., 2011. 165 s. 7. Kravtsov R. V., Karavaeva E. I. Biomeditsinskie tekhnologii: voprosy pravovogo regulirovaniya i otvetstven- 8. nosti. Sibirskiy yuridicheskiy vestnik. 2005. №3. S. 7-12. 9. Salagay O.O. Obshchie polozheniya prava Evropeyskogo Soyuza, primenimye k kletkam i tkanyam cheloveka. 10. Meditsinskoe pravo. 2011. №5. S. 6-11. 11. Taras'yants E.V. Mezhdunarodnaya zashchita i pooshchrenie prav cheloveka v oblasti biomeditsinskikh issledovaniy: 12. Dis. … kand. yurid. nauk. M., 2010. 197 s. 13. Sheverdin A.V. Sozdanie i ispol'zovanie biotekhnologiy: istoriya voprosa. Zhurnal rossiyskogo prava. 2012. 14. №6. S. 118-126. 15. Bignami F. et al. Participation of patients in the development of advanced therapy medicinal products. 16. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011;54(7):839-42. 17. Buchholz C.J. et al.The European hospital exemption clause-new option for gene therapy? Hum Gene Ther. 2012 18. Jan;23(1):7-12. 19. Liu J. et al. Skin and oral mucosa equivalents: construction and performance. Orthod Craniofac Res. 2010 20. Feb;13(1):11-20. 21. Ra J.C. et al. Stem cell treatment for patients with autoimmune disease by systemic infusion of culture-expanded autologous 22. adipose tissue derived mesenchymal stem cells. J Transl Med. 2011 Oct 21;9:181. 23. Regenerative Medicine - A Global Strategic Business Report. Global Industry Analysts, Inc., 2010, 381 P. 24. Russ H.A., Efrat S. Development of human insulin-producing cells for cell therapy of diabetes. Pediatr Endocrinol Rev. 25. 2011 Dec;9(2):590-7 26. Terskikh V.V., Vasiliev A.V. Cultivation and transplantation of epidermal keratinocytes. Int Rev Cytol. 27. 1999;188:41-72. 28. Thomas E.D. et al. Intravenous infusion of bone marrow in patients receiving radiation and chemotherapy. N. Engl. J. 29. Med. 1957.257 (11). 491-496. 30. Van Wilder P. Advanced Therapy Medicinal Products and Exemptions to the Regulation 1394/2007: How Confi dent 31. Can We be? An Exploratory Analysis. Front Pharmacol. 2012;3:12.

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Salagay, O.O. The approaches of the European Union to the regulation of cell therapy.