Discussion on Pharmaceutical Research Technical Requirements of Chemical Precursors for Radiopharmaceutical Preparation

Radiopharmaceuticals generally contain two kinds of components, i.e. radionuclides and non-radioactive fractions, which combine with each other to deliver the former to their targeted site, where the former play the diagnostic and therapeutic role by taking advantage of their radiation attribute. In this paper, chemical precursors of radiopharmaceuticals refer to non-radioactive fractions mentioned above, which are manufactured by chemical synthesis (hereinafter as chemical precursors for short) and dedicated to prepare radiopharmaceutical products, such as radiopharmaceutical kits and PET radiopharmaceuticals etc. At present, there is a lack of formal definition for chemical precursors, and technical guidelines or regulations for radiopharmaceuticals' research and development as well as chemical precursors in China, which have restricted the development of the industry. This paper aim to discuss the technical requirements of pharmaceutical research on chemical precursors by introducing related published guidelines of European Medicines Agency(MEA) to provide suggestions for this kind of pharmaceuticals' research and development in China.