[exclusive] overview of injection consistency evaluation: Qilu applied to lead, but Hainan Puli won the first? 6 varieties are deemed to be passed, and 3 have won the bid of "4 + 7 centralized procurement"

On May 11, 2017, the State Food and Drug Administration issued a notice (No 54, 2017) on Soliciting Opinions on relevant policies on encouraging innovation of pharmaceutical medical devices to implement full life cycle management of pharmaceutical medical devices (Draft for comments) Article 3 of the draft clearly pointed out that "re evaluation of listed injections" On December 22, 2017, CDE issued technical requirements for conformity assessment of listed chemical generic drugs (injections) (Draft for comments) After the oral solid preparation, the consistency evaluation of injection which has a great influence on the industry began Although the current evaluation policy of chemical injection consistency is still in the stage of consultation draft and has not been officially launched, the large-scale enterprises in the injection market have begun to rush the layout According to the statistics of drug registration and acceptance database, as of January 15, 2019, CDE has accepted 155 acceptance numbers of injection consistency, involving 66 varieties of 43 enterprises; among them, only 5 varieties of three or more declared enterprises are pemetrexed disodium for injection, bortezomib for injection, descitabine for injection, tegacyclin for injection and gemcitabine hydrochloride for injection, There are 16 varieties with 2 enterprises applying, and only 1 enterprise applying for 45 varieties In addition, 7 varieties have been successfully competed and passed the consistency evaluation Let's see more details with the editor (Note: at the end of the paper, there is a panoramic form of injection consistency evaluation declaration) Qilu pharmaceutical leads the injection consistency evaluation, and 18 varieties declaration has been accepted From the perspective of application enterprises, Qilu pharmaceutical injection consistency evaluation is far ahead of other enterprises in terms of acceptance number and application variety Qilu Pharmaceutical Co., Ltd has 18 acceptance number 10 varieties, Qilu Pharmaceutical (Hainan) Co., Ltd has 11 acceptance number 7 varieties In addition, Qilu Tianhe Huishi Pharmaceutical Co., Ltd also has one variety, a total of 18 injection varieties application consistency evaluation Price; followed by Jiangsu Haosen Pharmaceutical Co., Ltd., there are 13 acceptance No 7 varieties; Zhengda Tianqing and Jiangsu Hengrui do not fall behind, respectively, there are 11 acceptance No 7 varieties and 11 acceptance No 8 varieties of injection application consistency evaluation Table 1: Top 6 enterprises applying for injection consistency evaluation are favored by pemetrexed disodium, with 4 enterprises applying for it From the perspective of the declared varieties, pemetrexed sodium for injection is undoubtedly the most popular variety, with the largest number of application acceptance, up to 8, and the first enterprise to apply for up to 4 varieties; ceftriaxone sodium for injection and ropacaine hydrochloride injection, with 7 acceptance numbers; irinotecan hydrochloride injection, parecoxib sodium for injection and other 5 varieties of application acceptance numbers; injection There are 5 application acceptance numbers for 2 kinds of desetabine and docetaxel injection In addition, there have been 3 enterprises applying for four kinds of products, i.e bortezomib for injection, tegacyclin for injection, gemcitabine hydrochloride for injection and dexamethasone for injection It is worth mentioning that pemetrexed disodium for injection of Sichuan Huiyu Pharmaceutical Co., Ltd., which is a "joint product at home and abroad and listed in the EU", is the only chemical generic drug for injection nominated in the notice on Soliciting Opinions on the first batch of varieties included in the catalogue of chemical drugs listed in China, and finally included in the catalogue of drugs listed in China It is allowed to use the identity of "through consistency evaluation" and enjoy relevant policy benefits through consistency evaluation In addition, according to the pharmaceutical intelligence data, there are 29 market approvals and 15 manufacturers of pemetrexed disodium for injection in China Besides Sichuan Huiyu pharmaceutical, there are also 3 enterprises in Jiangsu Haosen, Yangzijiang and Qilu pharmaceutical that are unanimously evaluated and declared Table 2 applies for conformity assessment of top107 injections Up to now, 7 injections have passed or deemed to have passed the conformity assessment Surprisingly, azithromycin for injection of Hainan Puli Pharmaceutical Co., Ltd was the first injection to pass the consistency evaluation according to the supplementary application, rather than the leading declaration enterprises such as Qilu, hausen or Zhengda Tianqing with a large number of declaration enterprises; the remaining six varieties all passed the consistency evaluation by entering the catalogue of drugs on the market in China, and passed the consistency evaluation, overtaking the vehicle in the corner In addition, up to now, only two enterprises have ever commented on paclitaxel for injection (albumin binding type) and flurbiprofen axetil injection 2 varieties, and only one enterprise has ever commented on the other six varieties Details are as follows: Table 3 details of approved or deemed approved injections Three of them are 4 + 7 centrally purchased, namely, pemetrexed disodium for injection in Huiyu, Sichuan Province, youmeizuomidine hydrochloride injection in Yangzijiang Pharmaceutical Co., Ltd and flurbiprofen ester injection in Beijing Taide In particular, the flurbiprofen axetil injection of Beijing Taide was included in the catalogue of Chinese listed drugs as "other drugs" In addition, azithromycin for injection of Hainan Puli Pharmaceutical Co., Ltd is proposed to be included in the list of 4 + 7 centralized procurement drugs, only the final flow standard In addition, according to the registration and acceptance database of smart drugs, so far there are 15 acceptance No 7 varieties of consistency evaluation has been approved It seems that the harvest time has come for enterprises with more evaluation on injection consistency of Qilu pharmaceutical, Zhengda Tianqing, Jiangsu Haosen pharmaceutical and Hengrui pharmaceutical Calcium levofloxacin and docetaxel for injection of Zhengda Tianqing, irinotecan hydrochloride injection of Qilu pharmaceutical, irinotecan hydrochloride injection, docetaxel hydrochloride injection of Hengrui and Jixi hydrochloride for injection of Haosen The review and approval status of tarbin and other heavy-duty products has been updated to "issued" Table 5 details of injection consistency evaluation reviewed and approved Annex: injection consistency evaluation application panorama data source: drug intelligence data statement: this point of view only represents the author, not the position of drug intelligence network, welcome to exchange and supplement in the message area; 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