Pharma Network January 5 , at a press conference held by the State Council Joint Prevention and Control Mechanism on December 31 , 2020 , Chen Zhifei , deputy director of the State Drug Administration , said that on the evening of December 30 , the State Drug Administration had approved the registration application for the new coronavirus inactivated vaccine of China Bio-Beijing , a pharmaceutical group , in accordance with the conditions .
December 23rd, on the basis of the research materials submitted on a rolling basis in the previous period, the State Drug Administration's Drug Review Center formally submitted an application for registration with conditions for listing.
drug audit center is immediately accepted. On the basis of the preliminary rolling review, the team of experts of
Pharmaceutical Review Center also conducted a comprehensive and detailed examination of the research data and data submitted by the applicant on safety, effectiveness and quality control, including pharmacology, toxicology research, Phase I, Phase II clinical trials, as well as Phase III. clinical trials conducted abroad, and data from pharmaceutical research such as large-scale production processes and quality control of Beijing companies, and verified the research activities carried out in China and domestic phase I and II clinical trials.
In addition, the Drug Verification Center of the State Administration has carried out on-site verification of the production site of the Beijing Company in accordance with the law, the Beijing Drug Administration has carried out the inspection of the quality management standards of the pharmaceutical production, the China Institute of Drug Biologics Inspection has conducted laboratory tests and quality standards for vaccine samples tested by the Beijing Company, etc., and has reviewed the basis submitted by the applicant. The vaccine protection data from the mid-phase analysis of large-scale double-blind placebo-controlled Phase III clinical trials have been published by Beijing Zhongsheng Corporation, which has published 79.34 percent, conducted a comprehensive analysis, and combined with the evaluation opinions and suggestions of third-party expert groups on conditional listing applications, as well as the opinions of the expert consultation meeting of the Pharmaceutical Review Center.
After a series of rigorous review, review, verification, testing and data analysis in accordance with the legal procedures, it is concluded that the known and potential benefits of the new coronavirus inactivated vaccine of China National Pharmaceutical Corporation in Beijing are greater than the known and potential risks, and fully meet the requirements of the pre-set conditional listing standards.
The State Drug Administration approved the conditional listing of the new coronavirus inactivated vaccine of China National Pharmaceutical Corporation in Beijing on December 30.
At the same time, the State Drug Administration will urge China Pharmaceutical Group Zhongsheng Beijing Company to continue to carry out Phase III clinical trials as planned in accordance with the law, to complete phase III clinical trials and other conditional post-market research quality and quantity, according to the progress of the study and the results obtained, as well as the abnormal reactions in post-market vaccination, timely update, supplementary vaccine instructions, labels, etc., and in accordance with the provisions of the drug regulatory authorities to apply for approval, or declaration.