A review of the regulatory framework for personalized bacteriophages registration

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Abstract

The increasing trend in antimicrobial resistance of pathogenic bacteria dictates the need for alternative solutions. Bacteriophages are bacterial viruses that kill their hosts during the lifecycle. The high specificity of phages makes the production of personalized cocktails the best option. Registration of drugs with variable composition lies beyond the current legal policies. In the present review, we studied the regulatory framework of the top 10 world economies from the point of personalized bacteriophages registration. We underlined procedures that countries can learn from each other.

About the authors

N. N. Landyshev

Institute of Medicine, RUDN University

Email: fake@neicon.ru
ORCID iD: 0000-0002-9289-6849

PhD student, Institute of Medicine

Moscow, 117198

Russian Federation

Ya. G. Voronko

Institute of Medicine, RUDN University

Email: fake@neicon.ru
ORCID iD: 0000-0003-0779-5742

Specialist student, Institute of Medicine

Moscow, 117198

Russian Federation

O. Yu. Timoshina

Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry of the Russian Academy of Sciences;
Central Research Institute for Epidemiology of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare

Email: fake@neicon.ru
ORCID iD: 0000-0001-8727-9734

junior researcher, Laboratory of molecular bioengineering; researcher, Laboratory for molecular diagnostics and epidemiology of reproductive tract infections

Moscow, 117997

Moscow, 111123

Russian Federation

S. N. Suslina

Institute of Medicine, RUDN University

Email: fake@neicon.ru

PhD (Pharmacy), Associate Professor, Head of the division of General pharmaceutical and biomedical technology

Moscow, 117198

Russian Federation

V. G. Akimkin

Central Research Institute for Epidemiology of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare

Email: fake@neicon.ru
ORCID iD: 0000-0003-4228-9044

academician of RAS, D. Sci. (Med.), prof., Head 

Moscow, 111123

Russian Federation

K. A. Miroshnikov

Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry of the Russian Academy of Sciences

Author for correspondence.
Email: kmi@ibch.ru
ORCID iD: 0000-0002-4468-4091

D.Sci. (Chem.), Major research associate, Head of Laboratory of molecular bioengineering

 Moscow, 117997

Russian Federation

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Copyright (c) 2020 Landyshev N.N., Voronko Y.G., Timoshina O.Y., Suslina S.N., Akimkin V.G., Miroshnikov K.A.

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This work is licensed under a Creative Commons Attribution 4.0 International License.

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