[exclusive] analysis report on drug acceptance of Chongqing in 2018
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Last Update: 2019-01-24
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Source: Internet
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Author: User
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Influenced by clinical verification, consistency evaluation and new policies on drug registration, the number of drug acceptances in 2016 and 2017 dropped significantly, and the total number of drug acceptances decreased significantly In 2018, the total amount of national acceptance basically returned to normal What's the situation of Chongqing in the field of drug declaration in 2018? See below 1、 According to the latest statistics of Chongqing drug registration and acceptance database, in 2018, CDE undertook 62 new drug registration applications in Chongqing with acceptance number (excluding reexamination, the same below), a decrease of 22.5% compared with 2017, accounting for only 0.84% of the total national acceptance In terms of the number of registration applications, Chongqing pharmaceutical companies have not come out of the influence Figure 1 drug acceptance in Chongqing from 2011 to 2018 the number of drug applications accepted by CDE in Chongqing in 2018 (calculated by acceptance number) ranks 18th in drug applications of all provinces and municipalities directly under the central government in China, which is one twelfth of the number accepted in Jiangsu Province in the whole year (see Figure 2) Figure 2 in 2018, the drug acceptance of CDE in all provinces and cities across the country is mainly based on the acceptance of chemical drugs, followed by traditional Chinese medicine, and the declaration of biological products began in 13 years, with 6 acceptance numbers in 2018 Figure 3 the specific analysis of the acceptance and review of registration of chemical drugs, traditional Chinese medicine and biological products in Chongqing from 2011 to 2018 is as follows: 1 in 2018, a total of 49 chemical drugs were accepted, including 0 new drugs, 11 generic drugs and 38 supplementary applications Chongqing has no new drug application this year (see Figure 4) Figure 4 acceptance of CDE Chongqing chemicals in 2011-2018 1.1 consistency evaluation Due to the influence of 2018 consistency evaluation cutoff point, there is no acceptance of new chemical drugs in Chongqing this year From the acceptance situation, it is mainly generic drugs and supplementary applications, including 19 consistency evaluations included in supplementary applications, accounting for 3.15% of the total acceptance of national consistency evaluation (if you want to know the specific situation, please pay attention to the registration and acceptance database of drug intelligence) Figure 5 in 2018, Chongqing Yaoyou Pharmaceutical Co., Ltd is the leader in the list of chemical drug consistency evaluation declaration for this year, with a total of 6 acceptance numbers Southwest Pharmaceutical Co., Ltd ranks second, Chongqing Huasen Pharmaceutical Co., Ltd and Chongqing shenghuaxi Pharmaceutical Co., Ltd rank third See the following table for specific acceptance: Table 1 acceptance of consistency assessment in Chongqing in 2018; 2 acceptance number of Chongqing Traditional Chinese medicine registration applications undertaken by CDE in 2018 is 7, including 1 new drug and 6 supplementary applications Figure 6 table 2 acceptance of traditional Chinese medicine in Chongqing from 2011 to 2018 Table 3 acceptance of biological products in Chongqing in 2018 a total of 6 acceptance numbers were accepted by CDE, including 5 new drugs and 1 supplementary application Figure 7 acceptance quantity of biological products in Chongqing from 2013 to 2015 Table 3 acceptance of biological products in Chongqing in 2018 remarks: in the statistical process, the data of pharmaceutical companies may be missing, welcome to add 2、 Review and approval of drug registration in Chongqing in 2018 According to the latest statistics of pharmacy intelligence registration and acceptance database, in 2018 (the start date of the status is from January 1, 2018 to December 31, 2018), 66 acceptance numbers (referring to the number of varieties that CDE has completed the technical review and handed over for approval, and the processing status includes the status of approval, approval or certification completion, calculated by the acceptance number) were concluded Figure 8 review quantity of drug registration in Chongqing in 2018 Table 4 approved clinical / approved production in Chongqing in 2018 data source: drug intelligence data statement: this opinion only represents the author, not the position of drug intelligence network, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.
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