State Drug Administration: Continue to severely crack down on new crown virus test agents illegal an

The State Drug Administration today (June 7) issued a notice on further strengthening the quality and safety supervision of the new crown virus testing agent. The notice requirements are as follows that the 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 crown 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 situation. The relevant work requirements are notified as follows:

1. Continue and strictly grasping product quality supervision

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 supremacy, and keep in mind the people's health. \"Big\", conscientiously implement the \"four strictest\" requirements, and implement the \"Regulations on the Supervision and Management of Medical Device\" in an all -round way, be careful, and make persistent efforts. Implement the main responsibilities of enterprises and use units, strictly implement the responsibility of local governments, and 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 the quality supervision of product development links

All provincial drug regulatory departments must further strengthen the guidance of the development and registration of new crown virus detection reagents, and and register for registration, and and register and declaration. Do a good job of verifying the registration quality management system of registration products, urge the registrate to carefully fulfill the main responsibilities, ensure that the product research and development process specifications are standardized, and the registration application materials are true, 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

All provincial drug regulatory departments should maintain the frequency of supervision in accordance with the requirements of the preliminary work, continue to organize professional forces against the new crowns in the area under the jurisdiction. Virus detection reagents registered and their trusted manufacturers carry out supervision and inspection, supervision and supervisionEnterprises strictly organize production in 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 and evaluation, etc. 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 drug supervision departments must further do a good job of supervision and inspection of new crown virus test agents, supervise and operate enterprises Organize business activities in strict accordance with regulations and specifications. 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 quality and safety supervision of the new crown virus nucleic acid testing agent in accordance with their duties. Check whether the product qualifications, purchase channels, and validity management of the new coronary virus nucleic acid test agent used by medical institutions (including third -party medical inspection institutions) meet the requirements and whether the quality is qualified. 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 should continue to strengthen the quality supervision and randomness of the new coronary virus detection reagent. The new coronal virus testing agent products produced by the trustee production enterprise will carry out full coverage of random inspection in accordance with the special random inspection plan organized by the State Administration. 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.

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

Drug supervision departments at all levels must conscientiously implement the \"four strictests\" requirements, supervise inspections, supervise sampling, complaints, complaints, complaints Report, Internet monitoring, windThe 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.

Local drug supervision departments at all levels must fully implement the requirements of this notice, analyze the quality and safety status of the new crown virus testing agent product, 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.

(CCTV reporter Yu Jingying)

(Source: CCTV News Client)

[Edit: Fu Ying]