Abstract：
Since the late 1950s, radiopharmaceuticals have been used for diagnosis and treatment in clinical nuclear medicine in China. Over the decades, China has successfully established a relatively sophisticated system for radiopharmaceutical production and management, supported by state-of-the-art facilities. With the rapid growth of the national economy, the radiopharmaceutical market in China is expanding at a remarkable pace. This burgeoning market has led to an escalating demand for clinical-stage radiopharmaceuticals, either produced domestically or imported. Despite this positive trajectory, the development and application of radiopharmaceuticals in China have been hindered by several challenges that persist, such as inadequate research, insufficient investment, limited availability of radionuclides, shortage of trained personnel in related fields, and imperfections in policies and regulations. In an exciting development, the regulation reforms implemented since 2015 have positively affected China\'s drug regulatory system. The introduction of the \"Mid- and Long-Term Development Plan (2021-2035) for Medical Isotopes\" created concurrently an opportune environment for the advancement of innovative radiopharmaceuticals. In this review, we aim to provide an overview of the approval process for novel radiopharmaceuticals by the National Medical Products Administration and the status of radiopharmaceuticals in research and development in China. Preclinical development and clinical translation of radiopharmaceuticals are undergoing rapid evolution in China. As practitioners in the field in China, we provide several practical suggestions to stimulate open discussions and thoughtful consideration.
摘要：
自1950年代末以来，放射性药物已被用于临床核医学的诊断和治疗。几十年来,中国成功建立了较为完善的放射性药物生产和管理体系,由最先进的设施支持。随着国民经济的快速增长,中国的放射性药物市场正在以惊人的速度扩张。这个新兴的市场导致了对临床阶段放射性药物的需求不断增长，无论是国内生产的还是进口的。尽管有这种积极的轨迹，放射性药物在中国的开发和应用受到了一些持续存在的挑战的阻碍，例如研究不足，投资不足,放射性核素的可用性有限，相关领域训练有素的人员短缺，以及政策法规的不完善。在一个令人兴奋的发展中，2015年以来实施的监管改革对我国药品监管体系产生了积极影响。“医用同位素中长期发展计划（2021-2035年）”的出台同时为创新放射性药物的发展创造了有利的环境。在这次审查中,我们的目标是概述国家医药管理局对新型放射性药物的审批流程以及放射性药物在中国的研发状况。在中国，放射性药物的临床前开发和临床转化正在迅速发展。作为中国该领域的从业者，我们提供了一些切实可行的建议，以激发公开讨论和深思熟虑。
