Separate Issues of Naming Biomedical Cell Products: Russian and Foreign Experience
- Authors: Davidenko A.O.1
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Affiliations:
- Academy of Labor and Social Relations
- Issue: Vol 18, No 2 (2022)
- Pages: 191-194
- Section: Articles
- URL: https://journals.eco-vector.com/2541-8025/article/view/531997
- ID: 531997
Cite item
Abstract
This article examines the current practice of naming biomedical cell products in the Russian Federation. In particular, the author notes the lack of legal regulation of this issue. On the other hand, on the territory of the EAEU, high-tech medicines are equated to medicines and the practice of their names is similar to the practice of names of medicines in accordance with the international non-proprietary name. The aim of the research is to consider possible scenarios for regulating the practice of naming biomedical cell products at the legislative level in Russia. Research methodology: analysis of the current legislative framework of the Russian Federation in the field of biomedical cell products and foreign experience in the field of naming such medical products. The novelty of the research lies in the determination of a possible scenario for the regulation at the legislative level in the Russian Federation the issue of the correct compilation of the name of biomedical cell products.
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About the authors
Anastasia O. Davidenko
Academy of Labor and Social Relations
Email: nastya.anastasya96@yandex.ru
Postgraduate student of the Department of Civil Law and Procedure Moscow, Russian Federation
References
- Federal Law No. 323-FZ of 08.06.2016 (as amended on 27.12.2019) «On biomedical cell products». -[Electronic resource]. Access mode: http://pravo.gov.ru/proxy/ips/?docbody=&nd=102402596.
- Order of the Ministry of Health of the Russian Federation No. 281n dated 31.05.2017 [Electronic resource]. Access mode: https://docs.cntd.ru/document/436743536
- Order of the Ministry of Health of the Russian Federation No. 567n dated 28.08.2017. -[Electronic resource]. Access mode: https://cdnimg.rg.ru/pril/145/12/71/48162.pdf
- Decision of the Council of the Eurasian Economic Commission No. 78 of 03.11.2006 «On the Rules of registration and examination of medicines for medical use». -[Electronic resource]. Access mode: https://docs.eaeunion.org/docs/ru-ru/01411969/cncd_21112016_78.
- The Federal Service for Supervision in the Field of Healthcare has issued GENERIUM JSC the first license in Russia for the production of biomedical cell products. -[Electronic resource]. Access mode: https://vladimir.tpprf.ru/ru/news/358657
- SOPP 8426: Assignment of Biological and Drug Product Proper Names and Biological Suffixes. [Электронный ресурс]. Режим доступа: https://www.fda.gov/media/96219/download.
- World Health Organization. Discussion on Nomenclature for Cell Therapy Products and Proposal for Biosimilars, 15 October 2012. [Электронный ресурс]. Режим доступа: https://www.who.int/medicines/services/inn/INN_cell_therapy_report_2014.pdf.
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