Regulation of Radiopharmaceutical Products
https://doi.org/10.30895/1991-2919-2022-12-4-379-388
Abstract
The fast development of diagnostic and therapeutic radionuclide technologies requires enhanced legislative regulation of radiopharmaceuticals. The article addresses the challenge of classifying radiopharmaceuticals depending on the manufacturing technology, radionuclide properties, and clinical use. The review covers the current legislative and regulatory requirements for radiopharmaceutical medicinal products. It also describes the trends in radiopharmaceutical regulation development in Russia and the Eurasian Economic Union, taking into account the corresponding legislative frameworks.
About the Authors
V. V. Kosenko
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
Valentina V. Kosenko, Cand. Sci. (Pharm.)
127051, Moscow, Petrovsky Blvd, 8/2
A. A. Trapkova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
Alla A. Trapkova, Cand. Sci. (Biol.)
127051, Moscow, Petrovsky Blvd, 8/2
S. N. Kalmykov
Lomonosov Moscow State University
Russian Federation
Russian Federation
Stepan N. Kalmykov, Dr. Sci. (Chem), Professor, Academician of the Russian Academy of Sciences
119991, Moscow, Leninskie Gory, 1/3
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Supplementary files
Review
For citations:
Kosenko V.V., Trapkova A.A., Kalmykov S.N. Regulation of Radiopharmaceutical Products. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation. 2022;12(4):379-388. (In Russ.) https://doi.org/10.30895/1991-2919-2022-12-4-379-388
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