Nuclear medicine is an important part of modern medicine, and it plays an irreplaceable role in the early and accurate diagnosis, treatment, efficacy monitoring and individualized treatment of diseases, especially major diseases such as tumors, cardiovascular and central nervous system diseases. With the aging of the population, the incidence of the above-mentioned major diseases has also increased year by year, with 4.5 million new cancer patients and about 11.39 million coronary heart disease patients in 2020. The role of nuclear medicine in precision diagnosis and treatment in these fields is becoming increasingly prominent, and the people's demand for nuclear medicine is increasing.

       In June 2021, eight ministries and commissions, including the China Atomic Energy Agency, the National Health Commission, the Food and Drug Administration, and the Medical Insurance Bureau, jointly issued the "Medium and Long-term Development Plan for Medical Isotopes (2021-2035)", in order to encourage the research and development and application of radiopharmaceuticals, in April 2023, the State Medical Products Administration issued the "Opinions on Reforming and Improving the Management System for the Evaluation and Approval of Radiopharmaceuticals", and the National Health Commission and 11 ministries and commissions also issued the " Promote the research and development and application of radiopharmaceuticals", encourage the innovation of radiopharmaceuticals oriented by clinical value, give priority to the review and approval of radiopharmaceutical registration applications, improve the radiopharmaceutical review system, and reflect the characteristics of radiopharmaceuticals in acceptance, technical review, verification, inspection and other links. With the strong support of national policies, the number of nuclear drug research and development and products submitted for review has gradually increased in the past two years.

       The production of radiopharmaceuticals involves nuclides, precursors/ligands, nuclide generators, cold pill boxes, radioactive preparations and other parts. Based on the characteristics of radiopharmaceuticals, nuclides, precursors/ligands, and nuclide generators (used for the production of medical nuclides) have no pharmacological activity by themselves, and are prepared to generate pharmaceutical active ingredients (nuclide labeled compounds) for clinical use through labeling operations before use. Due to its own nature, it is neither an API nor a pharmaceutical excipient. At present, the specific products of supervision have encountered many difficulties in acceptance, technical review, verification, inspection and other links.

       1. The cold medicine box is a preparation containing non-radioactive components (ligands and excipients, etc.), and its production, inspection and transportation processes do not involve radioactivity. At present, the cold medicine box is managed according to the discharge of drugs, and it needs to be produced in the pharmaceutical factory that has obtained the "Radiopharmaceutical Production License". Due to historical reasons, the production scale of domestic cold pill box manufacturers holding the "Radiopharmaceutical Production License" is small (2000~4000 pieces/batch), which is completely unable to meet the requirements of domestic nuclear drug development.

       2. The current charging methods for nuclear drugs used in clinical practice vary in China. The area covered by non nuclear pharmacies still obtains imaging agents through self labeling, and the cost will include nuclides and precursor drug kits. Some nuclides are generated through ordered generators, which will naturally decay, but the clinical fees are the same as ordinary chemical drugs, that is, zero price management is implemented; Regions with nuclear pharmacies can provide finished nuclear drugs, but prices vary across the country and charging methods vary, even resulting in a cost-benefit inversion phenomenon.

       3. The online and pricing models of nuclear drugs are also not unified. Currently, with the increasingly standardized management of nuclear drugs, more and more provinces are also demanding that nuclear drugs be publicly displayed on the internet. Due to the varying dosages used by patients, as well as the unique half-life of nuclides in nuclear drugs, the entire usage process is completely different from that of chemical drugs. Moreover, due to the decay loss during transportation and storage, it is difficult to unify the hanging mode and price.