放射性药物的发展状况及监管思考

Development status and supervision consideration of radiopharmaceuticals

目的:概述放射性药物的发展状况及其发展面临的问题,从监管角度为促进国内该行业发展提供参考建议。方法:针对放射性药品上市情况、国内放射性药物生产状况进行梳理分析,比对国内外对放射性药物监管出台的相关法规指南,并对这一领域国内发展面临的主要问题进行总结分析。结果与结论:相较于国际先进监管机构,我国制定的放射性药物的相关法规及指南仍有待完善。建议相关监管机构对放射性药品企业发展进行政策支持与引导,加强多部门间的沟通,共建监管体系,同时注重专业化队伍建设,进行科学监管,以促进国内该行业发展。

Objective:To summarize the development situation of domestic radiopharmaceuticals industry and its existing problems and provide reference and suggestions for promoting the development of this industry in China from the perspective of supervision.Methods:The market situation and domestic production status of radiopharmaceutical are sorted out and analyzed,and the relevant domestic and foreign regulations and guidelines for its supervision are compared,and the main problems faced by domestic development in this field are summarized and analyzed.Results & Conclusion:Compared with international regulatory agencies,China’s regulations and guidelines for radiopharmaceuticals need to be improved.It is suggested that regulatory agencies should provide policy support and guidance for the development of radiopharmaceutical manufactories,strengthen the communication with other departments to build regulatory system together,and pay attention to the construction of professional teams to carry out scientific supervision so as to promote the domestic development of radiopharmaceuticals industry.