Legal regulation of biomedical cell products authorization and marketing in international practice



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Abstract

Scientific progress and advances in medicine and biology have contributed to emergence of new treatments based on delivery of living cells, genetic material and tissue engineering. The Federal Law N180-FZ “On Biomedical Cell Products” has taken effect in Russia opening a new stage in development of biomedical technologies, the main objective of which is to create a unified harmonious environment for the development, production and sale of safe and effective cell therapy products. At the same time, the system of legal regulation of the market of cellular products abroad has been functioning for more than 10 years and continues to develop actively. This review analyses international experience in regulation of medical biotechnologies market and identifies main features and current problems of existing scheme of biomedical products marketing as well as highlights main issues to be addressed while forming regulatory and legal filed for biomedical cellular products (BMCP) in Russia.

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About the authors

N. A Aleksandrushkina

Medical Research Center, M.V. Lomonosov Moscow State University; M.V. Lomonosov Moscow State University

Email: n.alexandrushkina@gmail.com

E. V Tarasova

Medical Research Center, M.V. Lomonosov Moscow State University; M.V. Lomonosov Moscow State University

P. I Makarevich

Medical Research Center, M.V. Lomonosov Moscow State University

L. A Gabbasova

Medical Research Center, M.V. Lomonosov Moscow State University; M.V. Lomonosov Moscow State University

Zh. A Akopyan

Medical Research Center, M.V. Lomonosov Moscow State University; M.V. Lomonosov Moscow State University

A. A Kamalov

Medical Research Center, M.V. Lomonosov Moscow State University

V. A Tkachuk

Medical Research Center, M.V. Lomonosov Moscow State University; M.V. Lomonosov Moscow State University

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