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The drug regulatory department has inspected a total of 168 new coronavirus detection reagent manufacturers

The drug regulatory department has inspected a total of 168 new coronavirus detection reagent manufacturers

  • Categories:Industry News
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  • Time of issue:2020-08-10 14:39
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(Summary description)On August 5, the State Food and Drug Administration participated in the State Information Office to hold a regular briefing to introduce the approval and supervision of new coronavirus detection reagents. According to Wang Lanming, the inspector of the Medical Device Registration Department of the State Food and Drug Administration, while strengthening the emergency approval of new coronavirus testing reagents, the State Food and Drug Administration has adopted a series of measures in accordance with the decision and deployment of the Party Central Committee and the State Council to comprehensively strengthen the quality supervision of new coronavirus testing reagents. .

The drug regulatory department has inspected a total of 168 new coronavirus detection reagent manufacturers

(Summary description)On August 5, the State Food and Drug Administration participated in the State Information Office to hold a regular briefing to introduce the approval and supervision of new coronavirus detection reagents. According to Wang Lanming, the inspector of the Medical Device Registration Department of the State Food and Drug Administration, while strengthening the emergency approval of new coronavirus testing reagents, the State Food and Drug Administration has adopted a series of measures in accordance with the decision and deployment of the Party Central Committee and the State Council to comprehensively strengthen the quality supervision of new coronavirus testing reagents. .

  • Categories:Industry News
  • Author:
  • Origin:
  • Time of issue:2020-08-10 14:39
  • Views:
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On August 5, the State Food and Drug Administration participated in the State Information Office to hold a regular briefing to introduce the approval and supervision of new coronavirus detection reagents. According to Wang Lanming, the inspector of the Medical Device Registration Department of the State Food and Drug Administration, while strengthening the emergency approval of new coronavirus testing reagents, the State Food and Drug Administration has adopted a series of measures in accordance with the decision and deployment of the Party Central Committee and the State Council to comprehensively strengthen the quality supervision of new coronavirus testing reagents. .

   One is to promptly deploy provincial bureaus to strengthen supervision and inspection. For newly approved and registered new crown virus detection reagents, the State Food and Drug Administration immediately deployed the provincial drug regulatory bureau where the company is located to effectively strengthen the supervision and inspection of the manufacturing company, supervise the company to strictly implement the main responsibility, earnestly fulfill the relevant regulations, and strictly follow Product technology requires the organization of production to ensure the continuous and effective operation of the quality management system. Up to now, 13 provinces and municipalities including Beijing, Tianjin, Hebei and other provinces and cities have inspected 35 new coronavirus detection reagent manufacturers (involving 44 products) 168 times in their jurisdictions, and promptly urged the companies that found problems to rectify them in place. To ensure product quality and safety.

   The second is to organize the supervision and inspection of new coronavirus detection reagents. In order to further strengthen the supervision of epidemic prevention and control medical devices and fully guarantee product quality and safety, the State Food and Drug Administration has adopted various methods such as video scheduling, on-site supervision, and special inspections to carry out supervision of the supervision of epidemic prevention and control medical devices such as new crown virus detection reagents. guide. Actively participate in the national anti-epidemic material product quality and market order special rectification actions carried out by 7 departments including the General Administration of Market Supervision. At the same time, the State Food and Drug Administration organized a special inspection of approved manufacturers of new coronavirus detection reagents from June to July. Focus on checking the implementation of the main responsibilities of the new crown virus detection reagent manufacturer, including whether the production is organized in accordance with the registered product process and technical requirements, whether the quality management system is compliant and effective, the production or release of the product, and whether the label and instructions are approved for registration Consistent and so on.

   As of now, the special inspection work has been completed as planned, and no serious problems affecting quality and safety have been found in the manufacturers of new coronavirus detection reagents.

   The third is to strengthen the random inspection of the quality of new coronavirus detection reagents. In order to further strengthen the quality supervision of new coronavirus detection reagents and prevent substandard products from entering the market, the State Food and Drug Administration has organized a full coverage sampling test of new coronavirus detection reagents, and no substandard products have been found. At the same time, the State Food and Drug Administration is also taking the spot check of new coronavirus detection reagents as a starting point to promote local regulatory agencies to improve testing capabilities. Local drug regulatory agencies are stepping up to implement territorial responsibilities, improve laboratory equipment and conditions, and strengthen laboratory capacity building. Meet the regulatory needs of new coronavirus detection reagents.

   In the next step, the drug supervision system will continue to do a good job in the supervision and management of new crown virus detection reagents, strengthen supervision and inspection of production enterprises, supervise enterprises to implement main responsibilities, and ensure product quality and safety.

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