Technical Guidelines for Non-clinical Research of Radioactive In vivo Diagnostic Drugs

In order to promote and standardize the research and development of radioactive in vivo diagnostic drugs in my country, on February 24, under the deployment of the National Medical Products Administration, the Center for Drug Evaluation organized the formulation of the “Technical Guidelines for Non-clinical Research of Radioactive In vivo Diagnostic Drugs”, which was approved by the State Drug Administration. It will be released after review and approval by the Administration, and it will come into force on the date of release.

Radioactive in vivo diagnostic drugs are a class of in vivo radiopharmaceuticals used to obtain images or functional parameters of target organs or diseased tissues in the body and diagnose diseases. They can be used for physical examination screening, disease diagnosis, and organ structure/function evaluation.

Radioactive in vivo diagnostic drugs generally consist of two parts: a radionuclide and a non-radioactive part. The non-radioactive part is a ligand or carrier that binds to the radionuclide and delivers it to a specific part of the body. Radionuclides are unstable nuclides that can spontaneously decay and release positrons and/or gamma rays. The gamma rays emitted by them (positrons emit gamma rays through annihilation) can be detected by special detectors outside the body. The non-radioactive part is usually derived from organic molecules, such as carbohydrates, esters, nucleic acids, peptides, antibodies, and so on.

In this guiding principle, the ingredients in the final product of radioactive in vivo diagnostic drugs except for the active molecules that perform imaging functions are collectively referred to as non-radioactive components. Non-radioactive components usually include unlabeled ligands or carriers, Isotope ligands or carriers, active molecules decayed products, auxiliary materials (such as reducing agents, stabilizers, antioxidants, etc.), impurities, residual solvents, etc. With the development of various disciplines such as molecular biology, pathophysiology, pharmacy, and nuclear medicine, the research and development of radioactive in vivo diagnostic drugs has entered a stage of rapid development.

This guiding principle provides detailed explanations from pharmacodynamic research, pharmacokinetic research/toxicokinetic research, and toxicology research. It also indicates that the guiding principle only represents the current views and understanding of the drug regulatory authority , It is not mandatory and legally binding. With the development of new technologies, the relevant content will continue to be improved.