State Food and Drug Administration: implement the management of "one enterprise, one policy, one product, one file" for COVID-19 therapeutic drugs
2023-01-13
According to the official website of the State Food and Drug Administration, Li Li, secretary of the Party Leadership Group of the State Food and Drug Administration, conducted an investigation at the Food and Drug Audit and Inspection Center (National Vaccine Inspection Center) on January 11. He stressed that we should earnestly implement the "four strictest" requirements, comprehensively strengthen the supervision and inspection of epidemic prevention drugs and equipment, firmly hold the bottom line of quality and safety, and serve to ensure the overall situation of epidemic prevention and control in the new stage. Li Li pointed out that the current epidemic prevention and control has entered a new stage, and the inspection center and drug inspection institutions at all levels in the country should comprehensively strengthen the supervision and inspection of epidemic prevention drugs and equipment from scratch to ensure the quality and safety of products. We should make every effort to do a good job in the registration and verification of COVID-19 vaccine drugs and medical devices, maintain zero time difference with the review work, and ensure the rapid approval and listing of safe and effective vaccine drugs and medical devices. It is necessary to comprehensively strengthen the supervision and inspection of COVID-19 vaccine drugs and medical equipment manufacturing enterprises, and do a good job in patrolling the newly approved emergency use vaccine enterprises. It is necessary to coordinate and guide the drug supervision and inspection work around the country, implement the strictest on-site inspection for vaccine manufacturing enterprises, implement the management of "one enterprise, one policy, one product, one file" for COVID-19 therapeutic drugs, establish a supervision and inspection account, timely supervise and urge the rectification of problems found in supervision and inspection, and eliminate potential risks in the bud. Li Li pointed out that according to the working idea of "stressing politics, strengthening supervision, ensuring safety, promoting development, and benefiting the people's livelihood", we should make overall plans for epidemic prevention and control and daily work, development and safety, inspection and service, effectively strengthen the inspection of high-risk products such as vaccines and blood products, strengthen the construction of professional and professional inspectors, and constantly improve the quality and efficiency of inspection. We should do a good job in the supervision and inspection of clinical trials. The problems found in the clinical trials and inspections must be truthfully recorded and reflected. We should not miss any problem that affects the safety and effectiveness of drugs, and ensure the quality and safety from the source. (Outlook New Era)
Edit:qihang Responsible editor:xinglan
Source:People.cn
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