[exclusive] the outbreak period of consistency evaluation is coming: in September, the application reached a record high, and the injection and 289 catalogue of drugs are outstanding

From the beginning of the consistency evaluation of drug enterprise declaration in July 2017, the consistency evaluation work has been on the right track 2018 is the key year of the consistency evaluation, and the time flies by In a flash, three quarters of the time has passed in 2018 The consistency evaluation work has entered the sprint stage In the last September, the consistency evaluation application has been climbing all the way, and the outbreak period of the consistency evaluation has come Consistency evaluation reached a new record of historical application, 81 acceptance No 47 varieties were undertaken According to the pharmaceutical intelligence data, up to now, there are 429 acceptance numbers of CDE acceptance consistency evaluation, involving 171 varieties of 156 enterprises, including 81 acceptance numbers of CDE acceptance consistency evaluation in September 2018, which is the most accepted month since the implementation of the consistency evaluation work Whether from the acceptance number or from the variety, it is the most historical, and the acceptance number increased by 32.79% year-on-year in August The number of varieties is 5 more than that in August For details, please see the following figure: injection consistency evaluation is very popular 26 acceptance No 14 varieties are accepted It is worth mentioning that 26 injection acceptance No in September, accounting for more than 1 / 4 of the total acceptance No in September 14 varieties are involved, accounting for about 1 / 3 of the total acceptance No in September For details, please see the following table: acceptance details of injection consistency evaluation in September Among them, Qilu pharmaceutical's irinotecan hydrochloride injection has been accepted for the second time According to the pharmaceutical intelligence data, Qilu pharmaceutical has applied for acceptance of the consistency evaluation of irinotecan hydrochloride injection once in May this year, and the review status was updated to "issued" in July If there is no accident, follow the normal review steps, and according to the registration time of the pharmaceutical intelligence data Axis, it is expected to be completed again in May next year Registration time axis for consistency evaluation of irinotecan hydrochloride injection In addition, Qilu Pharmaceutical (including Qilu Hainan and Tianhe Wyeth pharmaceutical) added another 10 acceptance numbers and 5 varieties to obtain CDE in September, which is the most accepted enterprise for application consistency evaluation Among them, piperacillin sodium tazobactam sodium for injection, warfarin sodium tablet and sulfapiride tablet are the first application varieties, while risperidone tablet and warfarin sodium tablet are 289 catalog varieties For details, please refer to See the table below: in September, Qilu pharmaceutical's acceptance details of conformity assessment were accelerated in the application of 289 catalog varieties, 17 varieties with 30 acceptance numbers were undertaken according to the statistics of drug intelligence registration and acceptance database, and in September, a total of 30 289 catalog drug acceptance numbers were undertaken, involving 17 varieties of 23 enterprises The details of application acceptance are as follows: in September, the acceptance details of 289 catalog varieties consistency assessment are as follows: Among them, montmorillonite powder, cefuroxime ester tablets and amlodipine besylate tablets have passed the consistency evaluation However, the enthusiasm of enterprises for the application of these drugs seems to only increase After all, whether the consistency evaluation can be passed is closely related to whether the drugs owned by the pharmaceutical enterprises can continue to survive In September, two new enterprises of montmorillonite powder were declared, namely, Hunan Warner Pharmaceutical Co., Ltd and Hunan qianjinxiangjiang Pharmaceutical Co., Ltd., three new cefuroxime ester tablets, three new enterprises of Shijiazhuang Ouyi Pharmaceutical Co., Ltd., North China Pharmaceutical Co., Ltd., Hebei Huamin Pharmaceutical Co., Ltd and Suzhou Sinochem Pharmaceutical Co., Ltd., and three new enterprises of amlodipine besylate tablets, namely Chongqing Yaoyou Pharmaceutical Co., Ltd., Shanghai desino biomedical Co., Ltd and Sinopharm Rongsheng Pharmaceutical Co., Ltd., according to the data of pharmaceutical intelligence, Up to now, there are 8 enterprises applying for the consistency evaluation of montmorillonite powder, 5 cefuroxime ester tablets, 11 amlodipine besylate tablets 11 acceptance No 10 variety review is completed, and the first successful clearance of multiple varieties is a harvest season in September According to the drug intelligence registration and acceptance database, a total of 11 acceptance No 10 variety consistency evaluation review and approval are completed in September, as shown in the following table: September consistency evaluation review completion details table Among them, 4 varieties passed the consistency evaluation, and mirtazapine tablets, Azithromycin Capsules and tamsulosin hydrochloride sustained-release capsules were all the first ones to pass the consistency evaluation; metformin hydrochloride tablets of Beijing Sihuan Pharmaceutical Co., Ltd were the first enterprises to pass the supplementary application according to the consistency evaluation Previously, Ouyi, a stone drug, passed the consistency evaluation by entering the catalogue of drugs on the market in China, and the fast track passed the consistency evaluation Similar to Ouyi, many enterprises' drugs entered the catalogue of Chinese listed drugs in September, which is deemed to have passed the consistency evaluation, including Jiangsu Hengrui paclitaxel for injection (albumin binding type), Chongqing shenghuaxi levolacetan oral solution, dongyangguang moxifloxacin hydrochloride tablets and clarithromycin sustained-release tablets, etc In addition, it is worth noting that the processing status of four varieties of Chengdu Yuandong biological ubenimese capsule, Zhejiang Jingxin sertraline hydrochloride tablet, Zhejiang Jinhua kangenbeimoxilin capsule and Jiangsu Hengrui irbesartan tablet has been updated on October 8, from the completion of the preparation of the certificate to the issued document The update details are as follows: Among them, the last three varieties have been approved for production So far, Zhejiang Jingxin Pharmaceutical Co., Ltd has become the first enterprise to pass the consistency evaluation of sertraline hydrochloride tablets; Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd is the second enterprise to pass the consistency evaluation of Amoxicillin Capsules after Zhuhai United Pharmaceutical Co., Ltd.; Jiangsu Hengrui passed the consistency evaluation, and the three pillars of erbesartan tablets formed, and the other two enterprises are Zhejiang Huahai and Haizheng Pfizer Data source of acceptance details of irbesartan tablets consistency evaluation: statement of drug intelligence database: 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.