10 new coronavirus antigen self-test products listed state food and Drug Administration: do a good job in quality and safety supervision
2022-03-14
In order to effectively protect the quality and safety of COVID-19 antigen detection reagent products, the State Administration of Drug Administration recently issued the notice on the quality and safety supervision of COVID-19 antigen detection reagent (hereinafter referred to as the notice), calling for strengthening the registration related management work, strengthening supervision and inspection of production and operation links, and cracking down on illegal activities. 10 new coronavirus antigen self-test products on the market Recently, the State Council has issued the COVID-19 antigen detection application plan (Trial Implementation) to the New Coronavirus pneumonia epidemic prevention and control mechanism integrated group (hereinafter referred to as the "plan"). On March 12, the State Food and Drug Administration issued a notice approving the application change of self-test application of new crown antigen products of Nanjing nuovizan, Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Wanfu biology and Beijing huaketai biology. On March 13, the State Food and Drug Administration approved the registration applications of five new coronavirus antigen products, namely Wantai biology, rejing biology, Tianjin boosses biology, Chongqing Mingdao jietest biology and Beijing Lepu diagnosis. Since then, a total of 10 coronavirus antigen self-test products have been officially launched. The notice points out that according to the requirements of the plan that "community residents who need self-test can purchase antigen detection reagents for self-test through retail pharmacies, online sales platforms and other channels", they can obtain a drug business license or a medical device business license during the epidemic prevention and control period, Retail pharmacies and medical device enterprises with corresponding storage conditions can sell neocoronavirus antigen detection reagents. The notice requires that local drug supervision and administration departments at all levels should further improve the supervision and inspection of the enterprises engaged in the detection of COVID-19 antigenic reagents, supervise and guide enterprises to purchase COVID-19 antigen test agents from the registered medical device registrants and production and business enterprises with legitimate qualifications, do well the records of incoming inspection and sales, and provide appropriate facilities and equipment. Ensure that the transportation and storage conditions of products meet the marking requirements of labels and instructions. The notice emphasized that the COVID-19 antigen test reagents operated by the enterprise should be registered and approved and have the qualification certificate. Whether the product manual contains the instructions of the consumers themselves. For the medical device business enterprises engaged in online sales, they should also be urged to display the medical device business license in a prominent position on the main page of the website and the medical device registration certificate and other information on the product page. In addition, the provincial drug supervision and administration departments should continue to strengthen the monitoring and disposal of COVID-19 detection reagent network transaction information, and organize timely investigation and investigation of illegal and illegal clues. Strengthen the supervision and inspection of the third-party platform for online trading services of medical devices under its jurisdiction, supervise and guide them to strictly perform their obligations of real name registration, qualification review and business behavior management of online medical device operators, and timely stop and report to the drug regulatory department in case of illegal sales of medical devices. Strengthen supervision and inspection and crack down on violations of laws and regulations The notice also requires that all provincial drug regulatory departments should strengthen the guidance of R & D and registration links, do a good job in the verification of the registration quality management system of products applying for registration, and ensure that the R & D process of enterprises is standardized and the registration and application materials are true, accurate, complete and traceable. The relevant provincial drug supervision and administration departments should strengthen supervision and organize professional strength to strengthen the supervision and inspection of the COVID-19 antigen detection reagent registrants and their entrusted production enterprises in the administrative area, supervise and guide the enterprises to strictly implement the main responsibilities, organize production according to the registered product technology requirements, and ensure the quality management system runs continuously and effectively. Focus on whether the purchase of raw materials, quality control and environmental control of clean workshop meet the requirements, whether the potential risks such as unqualified products are controlled in time according to law, and whether the product manual contains the instructions for individual use by consumers. Urge enterprises to carefully make product sales records, ensure that relevant records meet traceability requirements, unblock after-sales service channels, and timely understand the use of products. Drug supervision and administration departments at all levels should attach great importance to the clues reflected in such channels as network monitoring, complaint reporting, public opinion monitoring, supervision and inspection, supervision and sampling inspection, etc., and shall strictly investigate and punish the illegal activities of unauthorized production and operation, production and operation, and unregistered COVID-19 antigen detection reagents. Those suspected of committing 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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