Regulation of the reserch and development of cellular drugs: the experience of the European Union and the United States



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Abstract

In the European Union and the United States, regulation of cell-based products for the placing on the market is rather extensive and multi-tiered. This is due to the complexities which emerge at the different steps of the process, e. g. when obtaining source materials (live human cells), further development, manufacturing and clinical investigation, as well as due to risks posed by cellular products for the patient and other people. In this paper we address foreign regulatory systems for products containing live cells as an active ingredient in order to establish the difference with the domestic system.

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About the authors

R. R Niyazov

Center for scientific consulting LLC

Email: pippin.2k@gmail.com

M. A Dranitsyna

Center for scientific consulting LLC

Email: pippin.2k@gmail.com

I. E Yasny

Inbio Ventures

Email: pippin.2k@gmail.com

E. V Gavrishina

Center for scientific consulting LLC

Email: pippin.2k@gmail.com

A. N Vasiliev

Center for scientific consulting LLC

Email: pippin.2k@gmail.com

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