[exclusive] overview of consistency evaluation in 31 provinces: Jiangsu, Zhejiang and Sichuan have been the big winners of the evaluation, and 11 regions "hang zero"

On February 6, 2016, the opinions of the general office of the State Council on the evaluation of the consistency of quality and efficacy of generic drugs was published, and the beginning of the evaluation of the consistency of generic drugs officially opened In order to improve the quality and safety of drugs, in response to the policy call, provinces actively issued policies to encourage enterprises to carry out the evaluation of the consistency of generic drugs; and in the stage of pharmaceutical reform, especially in the "4 + 7" urban drugs Today, the centralized purchase and use of drugs have officially entered the implementation stage, and the consistency evaluation is one of the key factors determining the fate of the centralized purchase of drugs So, at present, under the promotion of policies and the active cooperation of enterprises, what is the progress of drug consistency evaluation in all provinces and cities? Let's see The application for acceptance has been comprehensively evaluated nationwide, covering 28 provinces and cities according to the statistics of drug registration and acceptance database Up to now, a total of 28 provincial administrative regions in China have carried out the consistency evaluation work, which is in full progress In particular, the generic consistency evaluation of Hong Kong Aomei pharmaceutical factory has been applied by Beijing Representative Office As of March 21, a total of 1000 acceptance numbers of conformity assessment drugs accepted by CDE (calculated by supplementary application, the same below) Among them, Jiangsu Province is worthy of being a major province and a strong province in medicine The number of drug consistency evaluation applications, no matter the number of acceptance numbers or varieties, is far more than other provinces, reaching 187 acceptance numbers (108 varieties), about 1.7 times of the second Shandong Province, and 2.0 times of the third Zhejiang Province; Guangdong, Shanghai, Beijing, Sichuan and other places are closely followed; Guizhou, Inner Mongolia, Guangxi and other remote areas apply Less, only one variety in Guangxi and Ningxia has been applied for conformity evaluation; no enterprise has been applied in Xinjiang, Tibet and Gansu, see the following figure for details: As a major pharmaceutical Province, Jiangsu Province has received the most applications for consistency evaluation, which is also the expectation of the public Hengrui pharmaceutical, hausen pharmaceutical, Yangzijiang pharmaceutical, as well as China biopharmaceutical's Zhengda Tianqing and other pharmaceutical enterprises are all located here As of March 21, Jiangsu Hengrui Pharmaceutical Co., Ltd has applied for the number of consistency evaluation drugs, ranking first among all enterprises in Jiangsu Province, with 22 Acceptance numbers; next is Zhengda Tianqing Pharmaceutical Group Co., Ltd., with 19 acceptance numbers; in addition, Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd has also applied for 10 acceptance numbers and 7 varieties, ranking fifth; hausen pharmaceutical and Yang Pharmaceutical Co., Ltd Zijiang pharmaceutical group should not let it go It is worth mentioning that among the top five enterprises applying for conformity assessment in Jiangsu Province, more than half of the drug dosage forms declared are injections For example, nine of the 14 varieties of Zhengda Tianqing Pharmaceutical Group are injections, and the heavy-duty injections such as docetaxel injection, desetabine for injection and esmeralazole sodium for injection are listed Top 5 enterprises applying for conformity assessment in Jiangsu Province note: only calculated by individual units, no enterprise ownership In addition, Shandong Province, the second largest province in the number of application for conformity assessment, is mainly applied by Qilu pharmaceutical, accounting for 43% of the acceptance numbers of the whole Shandong Province, including 47 acceptance numbers and 25 varieties of Qilu Tianhe Huishi pharmaceutical, and Qilu Pharmaceutical (Hainan), located in Hainan Province, is also the main force of application in Hainan Province, with 14 acceptance numbers, 9 varieties and 8 products One is injection Compared with Shandong Province and Jiangsu Province, Zhejiang Province has a large dispersion in the number of enterprise applications, but it does not prevent Zhejiang Haizheng and Zhejiang Huahai pharmaceutical industry from becoming the leading enterprises in the consistency evaluation of Zhejiang Province, with 13 acceptance numbers of 11 varieties and 11 acceptance numbers of 9 varieties, respectively Approved details: products of 20 provinces have been evaluated, and Jiangsu, Zhejiang and Sichuan University won According to the statistics of drug registration and acceptance database, as of March 21, a total of 167 acceptance numbers and 80 varieties have passed the consistency evaluation, involving 20 provinces in total, and Jiangsu Province is still at the forefront, with 34 acceptance numbers and 24 varieties passing the consistency evaluation; Zhejiang Province is the second, with 27 acceptance numbers and 17 varieties; Anhui, Fujian, Hubei, Jiangxi and Liaoning have each passed the evaluation There are only two varieties from Henan, Guizhou, Heilongjiang and Shanxi In addition, Shaanxi, Yunnan, Jilin, Tianjin, Qinghai, Inner Mongolia, Guangxi and Ningxia have already applied for conformity assessment and have been accepted, but up to now, they have not achieved a breakthrough of zero; in addition, Xinjiang, Tibet and Gansu have not applied for conformity assessment in three regions, a total of 11 regions have passed the assessment It is worth mentioning that although Zhejiang is not the province with the largest number of applications and acceptances, or the province with the largest number of consistency evaluation products approved in accordance with supplementary applications, Huahai pharmaceutical, located in Zhejiang Province, is currently the enterprise with the largest number of conformity evaluation product specifications in China, including 17 product specifications (11 varieties) deemed to have passed the conformity evaluation in the catalogue of drugs entering China ）Among them, 14 products are the first to have been evaluated in China, and 6 varieties of irbesartan tablets, irbesartan hydrochlorothiazide tablets, lisinopril tablets, losartan potassium tablets, paroxetine hydrochloride tablets and risperidone tablets are selected in the centralized procurement of 4 + 7 urban drugs Huahai pharmaceutical industry consistency evaluation details note: the red font part is the 4 + 7 city drug centralized purchase selected varieties In addition, Sichuan Province took a surprise, and its application for acceptance of conformity assessment products was far less than that of Shandong, Zhejiang and Guangdong, but its batch number leaped over that of Shandong, becoming the third Province in terms of the number of approved conformity assessment products in China, with a total of 21 over assessment acceptance numbers, involving 16 varieties of 7 enterprises, of which Sichuan Kelun pharmaceutical industry contributed the most, and over assessment varieties accounted for half of the whole Sichuan Province, It has 11 acceptance numbers and 8 varieties, and escitalopram oxalate tablets are selected from 4 + 7 centralized procurement Details of consistency evaluation of enterprises in Sichuan Province the consistency evaluation of generic drugs in various provinces and cities is in full swing, more analysis will be seen in the next breakdown; 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