A review of the regulatory framework for personalized bacteriophages registration

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. © 2020 Izdatel'stvo Meditsina. All rights reserved.

Authors
Landyshev N.N. 1 , Voronko Y.G. 1 , Timoshina O.Y.2, 3 , Suslina S.N. 1 , Akimkin V.G.3 , Miroshnikov K.A.2
Number of issue
5
Language
Russian
Status
Published
Volume
65
Year
2020
Organizations
  • 1 Institute of Medicine, RUDN University, Moscow, 117198, Russian Federation
  • 2 Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, Moscow, 117997, Russian Federation
  • 3 Central Research Institute for Epidemiology, Federal Service for Supervision of Consumer Rights Protection and Human Welfare, Moscow, 111123, Russian Federation
Keywords
Bacteriophages; Drug approval; Personalized medicine; Review
Date of creation
20.04.2021
Date of change
20.04.2021
Short link
https://repository.rudn.ru/en/records/article/record/72779/
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