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    2021年中国食品药品安全依法治理的全面实践

    摘要

    食品药品安全关系到广大人民群众的身体健康与生命安全、公共卫生安全以及国家安全,将食品药品安全纳入法治轨道,探索与构建食品药品的治理之道,是近年来国家层面推动的重要改革之一。中国食品药品依法治理,应坚持保障食品药品安全是重大政治责任、坚持以人民为中心、根本上依靠法治以及坚持“四个最严”、党政同责等基本理念;同时,遵循科学管理、全过程预防控制、风险管理与社会共治等基本原则。在食品药品治理的制度层面,已建立了风险监测预警、质量安全标准、食品药品追溯、食品药品召回、网络交易监管等二十项制度;同时还创新构建食品安全风险评估、风险交流、药品上市许可持有人制度、药品储备和短缺药品供应管理、假药劣药管理、疫苗批签发制度、疫苗异常反应补偿制度、药品专利链接和专利保护期限补偿制度等十项制度。展望未来,应更加注重体制改革与法制改革的互动衔接、注重食品药品治理科学规律和现实情况的研究工作,注重食品药品法律体系的完善与平衡,注重统筹食品药品从源头到末端的全过程治理,注重食品药品法律法规内部逻辑体系的完善等全方位、立体化的制度构建与完善。

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    Abstract

    The safety of food and drugs is closely related to the health and life safety of the masses,the safety of public health and the safety of the country. Bringing food and drug safety into the track of rule of law and exploring and constructing food and drug governance is one of the important reforms promoted at the national level in recent years. To govern China’s food and drug industry in accordance with the law,we should adhere to the principle that food and drug safety is a major political responsibility,people-oriented,fundamentally dependent on the rule of law,the “four strictest” and other basic concepts. At the same time,it should follow the basic principles of scientific management,prevention and control of the whole process,risk management,common governance of society and other basic principles. At the institutional level of food and drug control,20 systems have been established,including risk monitoring and early warning mechanisms,quality and safety standards,food and drug traceability,food and drug recall,and online transaction supervision. At the same time,ten systems have been innovatively established,including food safety risk assessment,risk exchange,drug marketing authorizer system,drug supply management of drug reserves and shortages,counterfeit and substandard drug management,vaccine approval system,vaccine abnormal reaction compensation system,drug patent link and transfer compensation system. In the future,attention should be paid to the interaction and connection between system reform and rule of law reform,the research on the scientific rules and reality of food and drug governance,the perfection and balance of food and drug legal system,and the whole process of food and drug governance from source to end. In addition,in the future,we should also pay attention to the improvement of the internal logic system of food and drug laws and regulations and other all-round,three-dimensional system construction and improvement.

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    作者简介
    任端平:任端平,国家市场监管总局法规司副司长。
    郭富朝:郭富朝,中国政法大学博士研究生。
    毛睿涵:毛睿涵,北京工业大学文法学部学生。
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