REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot107910.21518/1561-5936-2019-5-22-26Original ArticleNomenclature of gene-therapy drugs: international experienceMokhovA. A.noemail@neicon.ruMerkulovV. A.noemail@neicon.ruMelnikovaE. V.noemail@neicon.ruPopovP. I.noemail@neicon.ruDudchenkoV. V.noemail@neicon.ruKoshechkinК. А.noemail@neicon.ruChaplenkoA. A.noemail@neicon.ruYavorskyA. N.noemail@neicon.ruKutafin Moscow State Law University (MSAL)Scientific center for expert evaluation of medical productsPeoples ' friendship UniversityPushchino State Institute of Natural Science051220195222618032022Copyright © 2019,2019The development of innovative gene therapy drugs for «personalized» therapy is becoming a megatrend of Biomedicine and the global biopharmaceutical market. Due to the question of the creation of the national nomenclature of these drugs is essential one. The article attempts to summarize the existing international experience in the development of the nomenclature of drug products for gene therapy, as well as to formulate national approaches to the nomenclature of drug products for gene therapy. The analysis shows the feasibility of harmonization of the national nomenclature of gene therapy drugs with the system of international nonproprietary names developed by WHO.gene therapy drugsnomenclaturelegislation and regulatory frameworkdrug circulationгенотерапевтические лекарственные препаратыноменклатуразаконодательная и нормативно-правовая базаобращение лекарственных препаратов1.Рекомендации по организации производства, оценке качества, проведению доклинических и клинических исследований генотерапевтических лекарственных препаратов. М.: «Лаборатория знаний», 2018, 95 с.2.http://clinicaltrials.gov.3.Statement from FDA Commissioner Scott Gottlieb, M. D. and Peter Marks, M. D., Ph.D., Director of the Center for Biologies Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629493.htm.4.Nomenclature schemes for advanced therapies (substances for gene therapies, substances for cell therapies, substances for cell-based gene therapies and virus-based therapies) https://www.who.int/ medicines/services/inn/Nomenclature_ schemes_advanced_therapies_201707.pdf.5.Олефир Ю.В. и др. Номенклатура биомедицинских клеточных продуктов. Ремедиум. 2017; 3: 6-11.6.FDA. Approved Cellular and Gene Therapy Products https://www. fda.gov/biologicsbloodvaccines/ cellulargenetherapyproducts/ approvedproducts/default.htm.