Regulatory considirations for cellular products development: how to accelerate the marketing authorisation in Russia and EAEU



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Abstract

The environment for the development of products containing live cells as an active substance is being set up in Russia for several years. However, the acceptable regulatory framework, which would have allowed to develop and place cell therapy products on the market, complying with international requirements for safety, efficacy, and quality, has not been yet established. Moreover, in addition to the national legal framework, the Eurasian Economic Union regulatory model has emerged that introduces in parallel a more straightforward pathway for the development and clinical use of this important medical product category. In this paper we address the domestic and Eurasian regulatory systems for products containing live cells as an active ingredient and suggest certain possible approaches to support this area of biotechnology.

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About the authors

R. R Niyazov

Center for Scientific Advice Ltd

Email: pippin.2k@gmail.com
Moscow, Russia

R. V Deev

I.I. Mechnikov North-Western State Medical University; Human Stem Cells Institute

Email: pippin.2k@gmail.com
Saint Petersburg, Russia; Moscow, Russia

MA. A Dranitsyna

Center for Scientific Advice Ltd

Email: pippin.2k@gmail.com
Moscow, Russia

I. E Yasniy

Inbio Ventures

Email: pippin.2k@gmail.com
Moscow, Russia

E. V Gavrishina

Center for Scientific Advice Ltd

Email: pippin.2k@gmail.com
Moscow, Russia

A. N Vasiliev

Center for Scientific Advice Ltd

Email: pippin.2k@gmail.com
Moscow, Russia

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