2003年抗击非典疫情胜利后，我国大力推进以“一案三制”为核心内容的应急管理体系建设，实现了应急管理体系建设的跨域式发展，疾病防控体系取得了长足的进步。2019年底，新冠肺炎疫情突袭全国，党中央成立应对新冠肺炎疫情工作领导小组，国务院启动联防联控机制，充分发挥中国的体制优势，调动全国各地的医疗卫生资源，全力支援湖北和武汉，以全国之力支持一省一市抗击疫情。新冠疫情爆发以来，全国各地开展了疫情防控狙击战，由于防护物资和药品区域性发展不平衡，各地都面临着防护物资短缺的问题。药品监督管理部门作为药品和医疗器械的监管部门，肩负着保障医疗物资供应、保证质量的重任，药监系统是抗击疫情应急体系中的重要组成部分。2018年，国家以“大市场、专药品”为发展目标，进行了药监系统第五次机构改革，目前正处于改革的调整期，应急机制有待完善，面对新冠疫情，药监系统该如何从监管、审批和服务角度来为疫情防控提供防护物资、治疗药品的支撑和保障是值得思考和研究的问题。本文以山西省药监局疫情应急处置案例为主体案例，基于药监系统监管、审批、服务三大核心职能的视角，运用协同治理“动力—行动—结果”的分析框架，从应急预案和实际执行层面的对比作为研究的切入点，对常规状态与应急状态的药监职能进行比较研究，紧扣应急状态监管、审批、服务职能的重要控制点，分析疫情应急过程中存在的问题，明确下一步重点工作，通过研究提出科学构建药监应急体系的政策建议。疫情发生之初，山西省药监局防疫工作面临重大的挑战，具体表现在储备物资不足、应急体系和制度滞后，跨部门协调难度大，专业团队能力和储备有限，药品物流保障不完善等几个方面。本文通过对山西省药监局应急机制的研究，结合实际情况提出了七点政策建议：一是制定完善应急预案，开展战平结合协同应急演练；二是加强垂直体系科学建设与管理，做好专业人才培养、培训和储备；三是加强应急物资保障体系建设，增强风险应对能力；四是建立健全网上应急监管、审批、服务协同服务平台，实现统一指挥分工明确、协调顺畅；五是完善应急医药物流保障体系，提升药店协同服务能力；六是设立医疗器械研发专项基金，提升研发能力和核心技术能力。七是构建适应高质量发展要求的社会信用体系和新型监管机制。最后，对本文的研究创新点和需要进一步研究问题进行了讨论。
Whether the national emergency management system is sound mainly depends on the efficiency and results of responding to all kinds of emergencies. As a super populous country, China has a variety of emergency events. After the victory of fighting against SARS in 2003, China vigorously promoted the construction of emergency management system with "one case, three systems" as the core content, realized the cross regional development of emergency management system construction, and promoted the great progress of disease prevention and control system. The novel coronavirus pneumonia outbreak in the country was launched in late 2019, and the public health emergency was launched in all parts of the country. Novel coronavirus pneumonia leading group was established by the Central Committee of the CPC. The State Council initiated joint defense joint control mechanism, exerting China's institutional advantages, mobilizing medical and health resources throughout the country, and fully supporting Wuhan and Hubei in fighting against the epidemic situation, and ensuring the people's war, general war and blocking war to win the epidemic prevention and control. After the outbreak of the new crown epidemic, the national general mobilization launched a sniper battle for epidemic prevention and control. Due to the imbalance of regional development of protective materials and drugs, all regions are facing the problem of shortage of protective materials. As the centralized management department of drugs and medical devices, drug supervision and administration department is responsible for ensuring the supply and quality of medical materials, which is an important part of the emergency system. In 2018, the fifth institutional reform of the drug supervision system was carried out with the development goal of "large market and specialized drugs". In the context of the reform, how the drug supervision system provides protection materials and treatment drug support for epidemic prevention and control from the perspective of supervision, approval and service is particularly worth considering.Based on the three core functions of supervision, approval and service of drug supervision system, this paper uses the analysis framework of "power action result" of collaborative governance, and takes the comparison between the emergency plan and the actual implementation as the research entry point to compare the routine state and emergency state drug supervision functions Study, closely follow the important control points of emergency state supervision, approval and service functions, analyze the problems existing in the emergency process of epidemic situation, make clear the next key work, and put forward policy suggestions for scientific construction of emergency system of drug supervision through research. At the beginning of the outbreak, the epidemic prevention work of Shanxi provincial drug administration was faced with major challenges, such as the shortage of reserve materials, the lag of emergency system and system, the difficulty of cross department coordination, the limited capacity and reserve of professional teams, and the imperfect logistics guarantee of drugs. Based on the study of the emergency mechanism of Shanxi Provincial Food and drug administration, this paper puts forward six policy suggestions according to the actual situation: first, to formulate and perfect the emergency plan, to carry out the coordinated emergency drill of war and peace; second, to strengthen the scientific construction and management of the vertical system, to do a good job in the cultivation, training and storage of professional talents; third, to strengthen the construction of the emergency material support system, to enhance the ability of identifying unknown risks; The fourth is to establish and improve the online emergency examination and approval collaborative service platform to achieve unified command and clear division of labor; the fifth is to improve the emergency medical logistics security system and enhance the collaborative service ability of drugstores; the sixth is to establish a special fund for medical device research and development to improve the research and development ability and core technical ability. The seventh is to build a social credit system and a new regulatory mechanism to meet the requirements of high-quality development. Finally, the innovation and further research of this paper are discussed.
