Problems of VirologyProblems of Virology0507-40882411-2097Central Research Institute for Epidemiology43510.36233/0507-4088-2020-65-5-2A review of the regulatory framework for personalized bacteriophages registrationLandyshevN. N.<p>PhD student, Institute of Medicine</p><p>Moscow, 117198</p>fake@neicon.ruhttps://orcid.org/0000-0002-9289-6849VoronkoYa. G.<p>Specialist student, Institute of Medicine</p><p>Moscow, 117198</p>fake@neicon.ruhttps://orcid.org/0000-0003-0779-5742TimoshinaO. Yu.<p>junior researcher, Laboratory of molecular bioengineering; researcher, Laboratory for molecular diagnostics and epidemiology of reproductive tract infections</p><p>Moscow, 117997</p><p>Moscow, 111123</p>fake@neicon.ruhttps://orcid.org/0000-0001-8727-9734SuslinaS. N.<p>PhD (Pharmacy), Associate Professor, Head of the division of General pharmaceutical and biomedical technology</p><p>Moscow, 117198</p>fake@neicon.ruAkimkinV. G.<p>academician of RAS, D. Sci. (Med.), prof., Head </p><p>Moscow, 111123</p>fake@neicon.ruhttps://orcid.org/0000-0003-4228-9044MiroshnikovK. A.<p>D.Sci. (Chem.), Major research associate, Head of Laboratory of molecular bioengineering</p><p> Moscow, 117997</p>kmi@ibch.ruhttps://orcid.org/0000-0002-4468-4091Institute of Medicine, RUDN UniversityShemyakin-Ovchinnikov Institute of Bioorganic Chemistry of the Russian Academy of SciencesCentral Research Institute for Epidemiology of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare161120206552592661411202014112020Copyright © 2020, Landyshev N.N., Voronko Y.G., Timoshina O.Y., Suslina S.N., Akimkin V.G., Miroshnikov K.A.2020<span class="fontstyle0">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.</span> <br /><br />bacteriophagesdrug approvalpersonalized medicinereviewбактериофагиобращение лекарственных средстврегистрация лекарственных средствперсонализированная фаготерапияобзор[1. Fleming A. Penicillin. Nobel lectures, physiology or medicine 1942–1962. Amsterdam, NL: Elsevier Publishing; 1964.][2. O’Neill J. Tackling drug-resistant infections globally: Final report and recommendations. London: HM Government and Welcome Trust; 2018.][3. Cisek A.A., Dąbrowska I., Gregorczyk K.P., Wyżewski Z. Phage therapy in bacterial infections treatment: one hundred years after the discovery of bacteriophages. Curr. Microbiol. 2017; 74(2): 277–83. https://doi.org/10.1007/s00284-016-1166-x][4. International Monetary Fund. World Economic Outlook: Global Manufacturing Downturn, Rising Trade Barriers. Washington: International Monetary Fund, Publication Services; 2019.][5. Pirnay J.P., De Vos D., Verbeken G., Merabishvili M., Chanishvili N., Vaneechoutte M., et al. The phage therapy paradigm: Prêt-à-porter or sur-mesure? Pharm. Res. 2011; 28(4): 934–7. https://doi.org/10.1007/s11095-010-0313-5][6. McCallin S., Oechslin F. Bacterial resistance to phage and its impact on clinical therapy. In: Górski A., Międzybrodzki R., Borysowski J., eds. Phage Therapy: A Practical Approach. Cham: Springer International Publishing; 2019: 59–88.][7. Oechslin F. Resistance development to bacteriophages occurring during bacteriophage therapy. Viruses. 2018; 10(7): 351. https://doi.org/10.3390/v10070351][8. Van Belleghem J.D., Dąbrowska K., Vaneechoutte M., Barr J.J., Bollyky P.L. Interactions between bacteriophage, bacteria, and the mammalian immune system. Viruses. 2019; 11(1): 10. https://doi.org/10.3390/v11010010][9. Hodyra-Stefaniak K., Miernikiewicz P., Drapała J., Drab M., Jonczyk-Matysiak E., Lecion D., et al. Mammalian Host- VersusPhage immune response determines phage fate in vivo. Sci. Rep. 2015; 5: 14802. https://doi.org/10.1038/srep14802][10. Fauconnier A. Phage therapy regulation: From night to dawn. Viruses. 2019; 11(4): 352. https://doi.org/10.3390/v11040352][11. Sullivan T. A tough road: cost to develop one new drug is $2.6 billion; approval rate for drugs entering clinical development is less than 12%. Policy and Medicine. 2019. Available at: https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drugis-26-billion-approval-rate-for-drugs-entering-clinical-de.html][12. Todd K. The promising viral threat to bacterial resistance: The uncertain patentability of phage therapeutics and the necessity of alternative incentives. Duke Law J. 2018; 68(4): 767–805.][13. Mossialos E., Ge Y., Hu J., Wang L. Pharmaceutical Policy in China Challenges and Opportunities for Reform. Copenhagen: WHO; 2016: 1–212.][14. Wu J.Z., Hsu Y.C. Decision analysis on entering the China pharmaceutical market: Perspectives from Taiwanese companies. Comput. Ind. Eng. 2018; 125: 751–63. https://doi.org/10.1016/j.cie.2018.05.054][15. de Souza Rp., Guedes H. The compounding pharmacy in Brazil: A pharmacist’s perspective. Int. J. Pharm. Compd. 2009; 13(1): 87–8.][16. Bertoldi A.D., Wagner A.K., Emmerick I.C.M., Chaves L.A., Stephens P., Ross-Degnan D. The Brazilian private pharmaceutical market after the first ten years of the generics law. J. Pharm. Policy Pract. 2019; 12: 18. https://doi.org/10.1186/s40545-019-0179-9][17. McCallin S., Sacher J.C., Zheng J., Chan B.K. Current state of compassionate phage therapy. Viruses. 2019; 11(4): 343. https://doi.org/10.3390/v11040343][18. Slater J.E., Menzies S.L., Bridgewater J., Mosquera A., Zinderman C.E., Ou A.C., et al. The US Food and Drug Administration review of the safety and effectiveness of nonstandardized allergen extracts. J. Allergy Clin. Immunol. 2012; 129(4): 1014–9. https://doi.org/10.1016/j.jaci.2012.01.066][19. Gandesiri S., Srujana M.P., Reddy Y.P., Rathinavelu M. Assessment of knowledge, attitude and perception towards good pharmacy practice in community pharmacists of India. World J. Pharm. Res. 2015; 4990(5): 1738–46.][20. Huys I., Pirnay J.P., Lavigne R., Jennes S., De Vos D., Casteels M., et al. Paving a regulatory pathway for phage therapy. Europe should muster the resources to financially, technically and legally support the introduction of phage therapy. EMBO Rep. 2013; 14(11): 951–4. https://doi.org/10.1038/embor.2013.163][21. Henein A. What are the limitations on the wider therapeutic use of phage? Bacteriophage. 2013; 3(2): e24872. https://doi.org/10.4161/bact.24872][22. Scheepers H.P.A., Langedijk J., Neerup Handlos V., Walser S., Schutjens M.H., Neef C. Legislation on the preparation of medicinal products in European pharmacies and the Council of Europe Resolution. Eur. J. Hosp. Pharm. 2017; 24(4): 224–9. https://doi.org/10.1136/ejhpharm-2016-001016][23. Pirnay J.P., Verbeken G., Ceyssens P.J., Huys I., de Vos D., Ameloot C., et al. The magistral phage. Viruses. 2018; 10(2): 64. https://doi.org/10.3390/v10020064]