Regulation of Radiopharmaceutical Products

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.

Keywords

• radiopharmaceuticals
• radiopharmaceutical precursors
• active pharmaceutical ingredients
• radionuclides
• theranostic products
• manufacturing
• hospital compounding
• pharmaceutical practice and distribution
• pharmacopoeia