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Our country's vaccine development work has always been among the global front-runners.

Published:

2021-11-26

China's vaccine development work has always been among the global top tier

In the State Council's joint prevention and control mechanism 2020 Year 12 Month 31 At the press conference on the day, Chen Shifei, Deputy Director of the National Medical Products Administration, stated that the National Medical Products Administration had on 12 Month 30 the evening of the day, conditionally approved the registration application for the inactivated COVID-19 vaccine of China National Pharmaceutical Group's China Biologic Beijing Company in accordance with the law.

　　12 Month 23 On the day, based on the previously submitted rolling research data, China National Pharmaceutical Group's China Biologic Beijing Company formally submitted a conditional marketing registration application to the Drug Evaluation Center of the National Medical Products Administration. The Drug Evaluation Center immediately accepted it. The expert team of the Drug Evaluation Center also conducted a comprehensive and detailed review of the safety, efficacy, and quality controllability research data and information submitted by the applicant based on the previous rolling review, including pharmacology, toxicology research, I phase, II phase clinical trials, as well as III phase clinical trials conducted abroad, and data on Beijing Company's large-scale production process and quality control pharmaceutical research, and conducted on-site inspections of the research activities carried out domestically and the domestic I 、 II phase clinical trial sites.

　　In addition, the National Medical Products Administration's Drug Inspection Center also legally conducted on-site registration production inspections at Beijing Company's production site, the Beijing Medical Products Administration conducted Good Manufacturing Practice inspections, the National Institutes for Food and Drug Control conducted laboratory testing and quality standard re-verification of vaccine samples from Beijing Company's trial production, and analyzed the vaccine efficacy data derived from the applicant's submission of mid-term analysis results of large-scale double-blind placebo-controlled III phase clinical trials. China Biologic Beijing Company has announced 79.34% , conducted a comprehensive analysis, and combined the evaluation opinions and suggestions from a third-party expert group on the conditional marketing application, as well as the opinions from the Drug Evaluation Center's expert consultation meeting. After a series of strict legal and procedural reviews, evaluations, inspections, tests, and data analyses, it was comprehensively concluded that the known and potential benefits of China National Pharmaceutical Group's China Biologic Beijing Company's inactivated COVID-19 vaccine outweigh the known and potential risks, fully meeting the preset conditional marketing standards.

　　The National Medical Products Administration legally approved the conditional marketing of China National Pharmaceutical Group's China Biologic Beijing Company's inactivated COVID-19 vaccine on 12 Month 30 the day. At the same time, the National Medical Products Administration will supervise China National Pharmaceutical Group's China Biologic Beijing Company to continue to carry out phase III clinical trials according to law and regulations and plans, ensuring that phase III clinical trials and other post-conditional marketing studies are completed with quality and quantity. Based on the progress of the research and the data obtained, as well as any adverse reactions during post-marketing vaccination, the vaccine's instructions, labels, etc., will be updated and supplemented in a timely manner, and approval or filing applications will be submitted to the drug regulatory authorities in accordance with regulations.

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