INTERNATIONAL APPROACHES TO THE REGULATION OF CELL THERAPY PRODUCTS

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Abstract

This article is a review of the main methods and approaches used in regulation of cell therapy products in the United States of America, Canada, European Union, Australia, Japan and South Korea. Intensive developments of scientific and technological aspects in stem cell and tissue engineering have led to the wide use of human cells and tissues for the treatment of various diseases and injuries of organs and tissues. Drug regulatory agencies of different countries are working on implementation of a risk-based legal framework with some common features. In many countries there is a multilevel control system that assures quality and safety of used  cell products. Competent authorities establish strict requirements  both to safety of the products and to the implemented standards of good laboratory, manufacturing, clinical and tissue practices.   

About the authors

N. V. Pyatigorskaya

I.M. Sechenov First Moscow State Medical University, Russian Federation

Author for correspondence.
Email: osipova-mma@list.ru
PhD, Deputy director for Research of Research Institute of Pharmacy, professor of the Department of Industrial Pharmacy, I.M. Sechenov First Moscow State Medical University Address: 45, Nakhimovsky avenue, Moscow, 117418; tel.: (499) 128-57-55 Россия

M. A. Tulina

I.M. Sechenov First Moscow State Medical University, Russian Federation

Email: mari_bel_90@mail.ru
postgraduate student of the Laboratory of Analysis and Technology of the Department of Drug Discovery of Research Institute of Pharmacy, I.M. Sechenov First Moscow State Medical University Address: 117418, Moscow, Nakhimovsky avenue, 45; tel.: (499) 128-57-55 Россия

Zh. I. Aladysheva

I.M. Sechenov First Moscow State Medical University, Russian Federation

Email: osipova-mma@list.ru
MD, associate professor of the Department of Industrial Pharmacy of I.M. Sechenov First Moscow State Medical University Address: 117418, Moscow, Nakhimovsky avenue, 45; tel.: (499) 128-57-55 Россия

V. V. Beregovykh

I.M. Sechenov First Moscow State Medical University, Russian Federation

Email: osipova-mma@list.ru
PhD, professor, cor. member of RAMS, assistant to the President of RAMS, Head of the Department of Industrial Pharmacy of I.M. Sechenov First Moscow State Medical University Address: 117418, Moscow, Nakhimovsky avenue, 45; tel.: (499) 128-57-77 Россия

References

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