Recently, the "14th five year plan" for national drug safety and promoting high-quality development (hereinafter referred to as the "plan") was officially released. The relevant person in charge of the State Food and Drug Administration recently answered a reporter's question on the formulation of the plan. It is understood that the emergency capacity improvement project is one of the 10 key construction projects proposed by the planning in the form of a column. It proposes to strengthen the reserve of advanced testing equipment and scientific research capacity, and focus on strengthening the scientific and technological research capacity of evaluation technical methods and hazard control methods of new drugs, medical devices and cosmetics In vitro diagnostic reagent testing and quality evaluation capability for major infectious diseases, and development capability of international and national reference materials required for key products and risk impurities. At the same time, strengthen the construction of national drug safety emergency capacity, carry out normalized drug safety emergency drills, and the drug regulatory departments at the national, provincial, municipal and county levels shall carry out emergency drills at least once every three years and organize drill evaluation. Novel coronavirus pneumonia system is a key cornerstone for the modernization of emergency management system and capability. The new crown pneumonia epidemic situation has led to a "big exam" and a new requirement for our drug safety emergency management system. The official said. The outbreak of the novel coronavirus pneumonia reflects the increasing risk of new diseases facing the human race, and raises new demands for drug research and development, safety and efficacy. How to strengthen the construction of national drug safety emergency capacity during the 14th Five Year Plan period? The official pointed out that the plan made special arrangements for the emergency management system and proposed to "strengthen the emergency system and capacity-building". We should continue to do a good job in the normalization prevention and control of New Coronavirus pneumonia, and strengthen the unified command and coordination of the emergency medical research and development, inspection and testing, system verification, evaluation, approval, monitoring and evaluation of the needed drugs and medicines, and improve the emergency shutdown system for the development of medical and medical equipment, and set up easy access to vaccines, therapeutic drugs and medical devices for the prevention and control of diseases. Review with report. At the same time, improve the emergency management system and mechanism. Improve the emergency plan for drug safety emergencies, improve the emergency review and approval, inspection and testing, supervision and inspection mechanism, and improve the drug storage and supply system. Strengthen the research on general and key technologies of drug inspection and evaluation, and improve the technical ability to quickly establish the inspection and evaluation of new drugs and medical devices, especially in vitro diagnostic reagents, vaccines and antibody drugs for major infectious diseases. In addition, the plan proposes to cultivate and improve emergency response capacity and implement emergency capacity improvement projects. Strengthen the construction of national drug safety emergency response capacity, strengthen the awareness of "all staff emergency", and take emergency management as the key content of the education and training of drug regulatory cadres. Establish a case base for drug safety emergency drill, strengthen emergency capacity training and practical drill at all levels, and improve emergency response capacity. (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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