According to the 2021 annual drug review report (hereinafter referred to as the report) released by the State Food and Drug Administration on the 1st, 47 innovative drugs were reviewed and approved in 2021, setting a new record. Two domestic novel coronavirus vaccines were successively included in the World Health Organization (who) emergency use list (Eul), and a group of novel coronavirus neutralizing antibody combination therapy drugs were listed through emergency review. According to the report, 2412 applications for clinical trials of new drugs (hereinafter referred to as ind) were accepted in 2021, a year-on-year increase of 55.81%, according to the statistics of registration application categories; 389 applications for new drug marketing license (hereinafter referred to as NDA), with a year-on-year increase of 20.43%; 1628 applications for innovative drug registration (878 varieties) were approved / proposed to be approved in 2021, with a year-on-year increase of 67.32%. According to the statistics of drug types, there were 39 innovative traditional Chinese medicines (39 varieties), with a year-on-year increase of 39.29%; There were 1029 innovative chemical drugs (463 varieties), with a year-on-year increase of 44.32%; There were 560 innovative biological products (376 varieties), with a year-on-year increase of 141.38%. In terms of breakthrough therapeutic drugs, among the registration applications accepted in 2021, 263 were applied for the application of breakthrough therapeutic drugs. After comprehensive evaluation and publicity, 53 (41 varieties) were included in the breakthrough treatment drug program, covering the diseases caused by novel coronavirus infection, non-small cell lung cancer, ovarian cancer and other indications. In terms of priority review and approval, according to the current measures for the administration of drug registration, a total of 115 registration applications (69 varieties) were included in the priority review and approval procedures in 2021. Among them, 41 drugs met the conditions for approval, accounting for 35.65%, and 34 new varieties, dosage forms and specifications of children's drugs meeting the physiological characteristics of children, accounting for 29.57%. The priority review resources of the drug review center have been increased year by year to favor the registration applications of new drugs, children's drugs and rare diseases with clinical advantages. In addition, in 2021, 81 registration applications (novel coronavirus vaccines and therapeutic drugs) included in the special approval procedures were reviewed and concluded, including 12 novel coronavirus vaccines ind and 5 novel coronavirus vaccines NDA (all approved for marketing with conditions), including 4 inactivated novel coronavirus vaccines (Vero cells) and 1 recombinant novel coronavirus vaccine (type 5 adenovirus vector); 15 novel coronavirus therapeutic drugs ind were approved, including 4 small molecule antiviral drugs, 9 neutralizing antibodies and 2 other drugs; It is recommended to approve 5 novel coronavirus therapeutic drugs NDA, which are Qingfei Paidu granules, Huashi Baidu granules, Xuanfei Baidu granules, novel coronavirus neutralizing antibody combination therapy drugs ambavizumab injection (brii-196) and romisizumab injection (brii-198); 44 supplementary applications related to novel coronavirus were approved. The report points out that in 2021, the global pandemic of COVID-19 is still in the development stage, the people's expectations for vaccines and drugs are increasing, and the international community's expectations for the safety of vaccines and drugs in China
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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