Foreign Experience of Legal Regulation of Names of Biomedical Cell Products
( Pp. 209-212)

More about authors
Davidenko Anastasia Olegovna рostgraduate student of the Department of Civil Law and Procedure
Academy of Labor and Social Relations
Moscow, Russian Federation
Abstract:
This article examines foreign and international experience in formulating the names of biomedical cell products and their various types. The relevance of the topic of this study is concerned with the practice of developing and subsequent registration of BMCP is just emerging in the Russian Federation, however, the use of international experience in the names of finished drugs is important for the subsequent certification and circulation of such products on the market. The purpose of the study is to consider foreign and international practice and standards in the formulation of the names of BMCP. Research methodology: analysis of the practice of naming biomedical cell products at the international level and abroad. The novelty of the research lies in the consideration of the foreign experience of BMCP names and the formulation of proposals for the introduction of international practice into Russian legislation.
How to Cite:
Davidenko A.O., (2022), FOREIGN EXPERIENCE OF LEGAL REGULATION OF NAMES OF BIOMEDICAL CELL PRODUCTS. Gaps in Russian Legislation, 3 => 209-212.
Reference list:
Approved Cellular and Gene Therapy Products. [Electronic resource]. Access mode: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products
Cellular & Noncellular Therapies Naming Scheme. [Electronic resource]. Access mode: https://www.ama-assn.org/about/united-states-adopted-names/cellular-noncellular-therapies-naming-scheme
INN Nomenclature Scheme For Cell Therapy Products (CTP). [Electronic resource]. Access mode: https://www.who.int/medicines/services/inn/INN_CTS_2015.pdf
Robertson J.S. The INN global nomenclature of biological medicines: A continuous challenge / W-K. Chui, A.A. Genazzani, S.F. Malan, A.L Manjavacas, de la R., R. Mignot, R. Thorpe, R. Balocco, M. Rizzi // ELSEVIER. Biologicals. 2019. Vol. 60. - P.15-23.
SOPP 8426: Assignment of Biological and Drug Product Proper Names and Biological Suffixes. [Electronic resource]. Access mode: https://www.fda.gov/media/96219/download
Keywords:
biomedical cell products (BMCP), international non-proprietary name, infix, affix (prefix, suffix), cell therapy products.


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