State Food and Drug Administration: fully guarantee the quality and safety of COVID-19 antigen detection reagents
2022-12-14
According to the official website of the State Food and Drug Administration, on December 13, the State Food and Drug Administration held a video scheduling meeting to strengthen the quality and safety supervision of COVID-19 antigen detection reagents, thoroughly implement the recent requirements of the joint prevention and control mechanism of the State Council on epidemic prevention and control, strengthen the implementation of the registrant's main responsibility and territorial supervision responsibility, and fully guarantee the quality and safety of COVID-19 antigen detection reagents. It is not allowed to carry out online sales activities in violation of laws and regulations. All registrants of COVID-19 antigen testing reagents, production and operation enterprises should fully implement the requirements of the Regulations on the Supervision and Administration of Medical Devices and its supporting rules and regulations, adhere to the problem orientation, strengthen the bottom line thinking, focus on quality and safety risks, benchmark the requirements of the quality management system, and comprehensively carry out troubleshooting and governance. As the first person responsible for product quality and safety, the registrant shall strictly implement the requirements of the production quality management specifications, shall not produce outside the quality management system, shall not change or increase the production address without authorization, shall not release unqualified products from the factory and market, and shall not modify the product labels and instructions at will. The operating enterprises shall strictly implement the requirements of the operation quality management specifications, shall not operate without the operation quality management system, shall not engage in business activities without certificates or qualifications, shall not operate or import products that do not meet the statutory requirements, shall not purchase products from illegal channels, shall not change the business site and warehouse address without authorization, shall not transport or store products in violation of regulations, and shall not carry out online sales activities in violation of laws and regulations; The third party platform of online trading service shall not provide online trading platform services in violation of laws and regulations. All registrants of COVID-19 antigen detection reagents, entrusted manufacturing enterprises, operating enterprises, and third-party platforms of online trading services should carefully check whether they have fully fulfilled their respective main responsibilities to ensure that the responsibilities are in place, the system is in place, risk prevention and control are in place, and quality management is in place. The Conference on Ensuring the Quality and Safety of Antigen Reagents stressed that drug regulatory authorities at all levels should earnestly implement the decisions and arrangements of the CPC Central Committee and the State Council to ensure the quality and safety of antigen reagents. It is necessary to strengthen the inspection of the quality management system, and organize professional forces to supervise and inspect the registrants of COVID-19 antigen detection reagents and their entrusted manufacturing enterprises, as well as the third-party platform of online trading services. If any violation is found and the product safety and effectiveness cannot be guaranteed, the enterprise shall be ordered to immediately suspend production, recall the defective products and dispose effectively; If the violation is serious, the medical device production license shall be revoked according to law, and the relevant responsible person shall be punished according to law. We will continue to strengthen the quality supervision and sampling inspection of COVID-19 antigen detection reagents, and carry out a full coverage sampling inspection of COVID-19 detection reagents produced by registrants and entrusted manufacturing enterprises in the jurisdiction. For the unqualified products in the supervision and sampling inspection, it is necessary to immediately take disposal measures, order the enterprise to suspend production, analyze and find out the reasons and carry out rectification, and do not resume production until they pass the re inspection by the provincial drug regulatory department. The problems and clues found in supervision and inspection, supervision and random inspection, complaints and reports, network monitoring, risk consultation and other work should be thoroughly investigated. All kinds of violations of laws and regulations should be investigated and dealt with strictly, seriously and quickly according to law. Those suspected of committing crimes shall be promptly transferred to the public security organ. Supervisors and other public officials involved
Edit：qihang Responsible editor：xinglan
Source：People.cn
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