Notice of the Comprehensive Department of the State Drug Administration on further strengthening the

All provinces, autonomous regions, municipalities, and Xinjiang Production and Construction Corps Drug Administration:

New coronary virus detection reagent is an important product required for the prevention and control of new coronary pneumonia. Since the outbreak of the epidemic, the State Drug Administration has continued to strengthen the quality and safety supervision of the new coronary virus testing agent, and has deployed and issued the \"Notice on the Special Inspection of New Crown Viruses Testing Disposes\" and \"Notice on the Development of New Coronary Virus testing agents. \"Notice on Further Strengthening the Supervision and Inspection of the New Crown Virus Detection Testing Eastern\", \"Notice on the Quality and Safety Supervision of the New Crown Virus antigen test agent\", \"Notice on Further Strengthening the use of product quality and safety supervision of new crown virus nucleic acid testing agents\", etc. \", etc.\" The documents have effectively promoted the implementation of the main responsibility of the enterprise and the implementation of territorial regulatory responsibilities, and effectively strengthened the quality and safety guarantee of the product. In order to comprehensively implement the special rectification work of drug safety, further strengthen the quality and safety supervision of the product quality and safety of the new coronary virus testing agent, ensure the quality and safety of the product, and effectively serve the overall situation of the epidemic prevention and control. Strictly grasp the quality supervision of product quality

Drug supervision departments at all levels must conscientiously implement the decision -making and deployment of the Party Central Committee and the State Council, adhere to the people's supremacy, life first, and keep in mind the people's health as the \"big of the country\", conscientiously implement the implementation The \"four most stringent\" requirements, comprehensively implement the \"Regulations on the Supervision and Administration of Medical Devices\", be cautious, and make persistent efforts to implement \"the strictest supervision\" for the new crown virus detection reagent. Responsibilities, strictly implement the responsibility of local governments, do not relax and grasp various supervision work, resolutely adhere to the bottom line of quality and safety, consolidate the hard -won regulatory results, and provide a strong guarantee for the prevention and control of the epidemic.

2. Continue to strengthen quality supervision of product development links

Provincial drug regulatory departments must further strengthen the guidance of the development and registration of new crown virus detection reagents, and do a good job of registration of registration products registration The quality management system verification work, supervise the registors to earnestly fulfill their main responsibilities, ensure that the product research and development process specifications are standardized, and the registration and declaration materials are real, accurate, complete and traceable. Registration of the new coronal virus detection reagent should effectively strengthen the quality management of the entire life cycle of the product, and assume responsibility for the safety and effectiveness of the products in the development, production, operation, and use of the whole process.

3. Continue to strengthen the quality supervision of product production links

Provincial drug regulatory departments should maintain the frequency of supervision in accordance with the requirements of the preliminary work, and continue to organize professional forces to conduct registered registered by the new coronary virus detection reagent in the area under its jurisdiction. Its trusted production enterprises carry out supervision and inspection, and supervise enterprises to organize production in strict accordance with regulations, specifications, standards, and registered product technical requirements to ensure that the quality management system is continuously compliant. It is necessary to focus on checking the source of product raw materials, production process specifications, product quality control, factory and listing release, adverse events monitoring, product quality analysis evaluationPrice. It is found that there are serious violations of production activities and cannot ensure the safety and effective product of the product. It is necessary to order enterprises to immediately suspend production and recall problems and effectively dispose of it. If the corporate violations are serious, the medical device production license shall be revoked in accordance with the law, and the relevant responsible person shall be punished according to law.

4. Continue to strengthen the quality supervision of product operation links

Municipal and county's drug supervision department must further do a good job of supervision and inspection of the new crown virus test agent operation enterprise, supervise and operate enterprises in strict accordance with regulations and regulations requirements in accordance with regulations and specifications Organize business activities. Focus on checking whether the new coronary virus test reagent operated by its operation has been approved and has a qualified certificate document, whether the purchase and sales channels are legal, whether the purchase inspection and sales records are true, accurate, complete, traceable, whether transportation and storage conditions meet the labels and instructions. See the requirements, whether to be equipped with compatible facilities and equipment.

5. Continue to strengthen product quality supervision in use

Municipal and county drug supervision departments must effectively strengthen the product quality and safety supervision of the new crown virus nucleic acid test agent in accordance with their duties, carefully check the medical institutions (including No. 1 Whether the product qualifications, purchase channels, and validity management of the new coronary virus nucleic acid test agent used by the three -party medical testing agency) use the quality. If illegal and illegal acts are discovered, the relevant departments will be notified in a timely manner. At the same time, in accordance with the \"Notice on Further Strengthening the Supervision of Full Chain Supervision of New Coronary Virus Nuclear Nuclear Nuclear Nuclear Nuclear Nuclear Nuclear) in accordance with the recent recently issued by the State Council's response to the new type of coronary virus pneumonia. Relevant departments do a good job of related work. All provincial pharmaceutical regulatory departments shall strengthen the supervision and guidance of product quality supervision work in the use of the city and county drug supervision departments.

6. Continue to strengthen product quality supervision and random inspection

Drug supervision departments at all levels must continue to strengthen the quality supervision and random inspection of the new coronary virus test reagents, and to the new crowns produced by registered and trusted production enterprises in the jurisdiction, The virus testing product products are carried out in accordance with the special random inspection plan organized by the State Administration to carry out full coverage. For unqualified products in supervision and random inspection, the drug regulatory department shall immediately take corresponding disposal measures to order enterprises to suspend production, analyze the reasons for unqualified and carry out rectification, and resume production after the re -examination of the provincial drug regulatory department will be resumed.

7. Continue to severely crack down on violations of laws and violations

Drug supervision departments at all levels must conscientiously implement the \"four strictest\" requirements, supervise inspection, supervision and random inspection, complaint reports, network monitoring, risks, risks, risks The problems and clues found in the work and other work should be tapped. For illegal and illegal acts such as unauthorized production and operation, illegal storage and transportation, and the use of unregistered or expired new crown virus detection reagents, etc., it is necessary to strictly investigate and deal with it in accordance with the law. Those who are suspected of constituting a crime shall be transferred to the public security organs in time. If regulators are suspected of misconduct, they shall be transferred to the disciplinary inspection and supervision organs in a timely manner.

The local drug regulatory authorities at all levels should fully implement the requirements of this notice, analyze and judge the quality and safety status of the new coronary virus test agent, and report to the local party committee and government in a timely manner.There are important situations to report the State Drug Administration in a timely manner.

Comprehensive Department of the State Drug Administration

June 7, 2022

Source: National Drug Administration

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