State Food and Drug Administration: novel coronavirus nucleic acid inspection institutions should standardize product quality management in procurement, acceptance and other links

2022-05-26

According to the official website of the State Food and drug administration, on May 24, xujinghe, deputy director of the State Food and drug administration, stressed when supervising and inspecting the quality and safety supervision of products in the use of novel coronavirus nucleic acid testing reagents in Beijing that novel coronavirus nucleic acid testing institutions should strictly perform their main responsibilities, standardize the quality management of products in the purchase, acceptance, storage and other use links, and pay special attention to the validity period of diagnostic reagents and their supporting products, Store and use relevant products in strict accordance with the requirements of medical device labels and instructions. On May 24, Xu Jinghe led the supervision and inspection team to Beijing Economic and Technological Development Zone to conduct on-site inspection on third-party medical inspection institutions such as Beijing anouda medical laboratory and Beijing Boao medical laboratory, and supervised the supervision of medical devices for epidemic prevention and control in Beijing. The supervision and inspection team went deep into the storage warehouse and Laboratory of nucleic acid testing reagents of Beijing anouda medical laboratory and Beijing Boao medical laboratory, inspected the procurement, acceptance, storage and use of nucleic acid testing reagents, understood the inspection equipment, infrastructure, site and personnel of the two inspection institutions, and focused on the construction and operation of medical device use quality management system of the two inspection institutions, And the qualification, expiry date, storage conditions, supplier audit and incoming inspection of novel coronavirus nucleic acid detection reagents used. Xujinghe pointed out that since the outbreak of COVID-19, the State Food and drug administration has attached great importance to the quality and safety supervision of drugs and medical devices for epidemic prevention and control, and taken the epidemic prevention and control as the most important work at present. In accordance with the "four strictest" requirements for drug safety, it has spared no effort to do a good job in the quality and safety supervision of drugs and medical devices, and resolutely prevented unqualified products from entering the market. Xujinghe required drug regulatory departments at all levels to effectively strengthen the product quality and safety supervision in the use of novel coronavirus nucleic acid detection reagents. Violations of laws and regulations such as the use of unregistered and expired products shall be seriously investigated and dealt with in accordance with the law. In case of any clue of violation of laws and regulations involving the responsibilities of other departments, it shall be reported to relevant departments in time. Clues and cases suspected of constituting a crime shall be transferred to the public security organ in time. (outlook new era)

Edit:Yuanqi Tang    Responsible editor:Xiao Yu

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