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On June 9, the State Food and Drug Administration held a teleconference on further strengthening the quality and safety supervision of new coronavirus detection reagents, summarizing the quality and safety supervision of new coronavirus detection reagents in the previous stage, exchanging work experience, and further promoting the continuous development of new coronavirus detection in the whole system. Reagent quality and safety supervision. Xu Jinghe, member of the party group and deputy director of the State Food and Drug Administration, attended the meeting and delivered a speech.

The meeting pointed out that since the outbreak of the new crown pneumonia epidemic, the national drug administration system has conscientiously implemented the decisions and deployments of the Party Central Committee and the State Council, fully implemented the “Regulations on the Supervision and Administration of Medical Devices”, adhered to the people’s supremacy and life first, and kept in mind that people’s health is the “bigger of the country”. Continuing to strengthen the quality and safety supervision of new coronavirus detection reagents has effectively promoted the implementation of the main responsibility of enterprises and territorial supervision responsibilities, and effectively strengthened the guarantee of product quality and safety. Recently, the first round of new coronavirus nucleic acid detection reagents in 2022 organized by the State Food and Drug Administration has fully covered the sampling inspection, and the inspection results have met the requirements.

The meeting emphasized that the quality and safety of new coronavirus detection reagents is directly related to the overall situation of epidemic prevention and control. The entire system must thoroughly implement the spirit of the instructions and instructions of the Party Central Committee and the State Council, fully implement the special rectification requirements for drug safety, further unify thinking, deepen understanding, improve political standing, and implement “the strictest supervision” on new coronavirus nucleic acid detection reagents. More resolute and powerful measures, be cautious and persistent, and continue to strengthen the quality and safety supervision of new coronavirus detection reagents. First, continue to strictly and meticulously carry out product quality supervision. Drug regulatory authorities at all levels must persevere and pay close attention to various regulatory work, supervise registrants to strictly implement the main responsibility of the enterprise, and resolutely hold the bottom line of product quality and safety. The second is to continuously strengthen the quality supervision of product development. Provincial drug regulatory authorities should further strengthen the guidance on the research and development and registration application of new coronavirus detection reagents, urge registrants to earnestly perform their main responsibilities, ensure that the product development process is standardized, and the registration application materials are true, accurate, complete and traceable. The third is to continuously strengthen the quality supervision of product production. All provincial drug regulatory authorities should continue to organize professional forces to supervise and inspect the registrants of new coronavirus detection reagents and their entrusted production enterprises in their respective jurisdictions, focusing on the operation of the quality management system, and finding serious violations in production activities that cannot guarantee the safety and effectiveness of products. , it is necessary to order the enterprise to immediately suspend production, recall the problem products and carry out effective disposal. If the enterprise violates the rules seriously, the medical device production license shall be revoked in accordance with the law, and the relevant responsible persons shall be punished in accordance with the law. Fourth, continue to strengthen the quality supervision of product operation links. The city and county drug regulatory departments should further supervise and inspect the business enterprises of new coronavirus detection reagents, and supervise the business enterprises to organize and carry out business activities in strict accordance with the requirements of laws and regulations. Fifth, continue to strengthen product quality supervision in the use link. The city and county drug regulatory departments should effectively strengthen the product quality and safety supervision of the use of new coronavirus nucleic acid detection reagents according to their duties, and carefully check whether the product qualifications, purchase channels, and expiration date management of the new coronavirus nucleic acid detection reagents used by medical institutions meet the requirements and whether the quality qualified. Sixth, continue to strengthen product quality supervision and sampling. Carry out full-coverage sampling inspections for the new coronavirus detection reagent products produced by registrants and entrusted manufacturers. Seventh, continue to severely crack down on violations of laws and regulations. Unauthorized production and operation, illegal storage and transportation, operation and use of unregistered or expired new coronavirus detection reagents and other violations of laws and regulations shall be investigated and dealt with quickly and severely in accordance with the law. If violations of laws and regulations involving the supervision duties of other departments are found, the relevant departments shall be notified in a timely manner; those suspected of constituting a crime shall be transferred to the public security organs in a timely manner; those suspected of dereliction of duty by supervisors shall be transferred to the discipline inspection and supervision organs in a timely manner.

At the meeting, the heads of Beijing Municipal Food and Drug Administration, Shanghai Municipal Food and Drug Administration, Xi’an Market Supervision Bureau of Shaanxi Province, Shanghai Zhijiang Biotechnology Co., Ltd., Shengxiang Biotechnology Co., Ltd., and Guangzhou Daan Gene Co., Ltd. They exchanged speeches and shared their work experience and practices around the company’s implementation of the whole life cycle quality management responsibility, ensuring product quality and safety, and continuing to strengthen product quality supervision in research, production, operation, and use.

The responsible comrades of the relevant departments and bureaus and directly affiliated units of the State Food and Drug Administration attended the meeting at the main venue. Relevant responsible comrades from the Food and Drug Administration of the provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps attended the meeting at the branch venue.

Ningbo ALPS Medical Report