[heavyweight] consistency acceptance number exceeded 408, and the latest development analysis of 149 pharmaceutical enterprises

As of September 28, 2018, the acceptance number of consistency evaluation undertaken by CDE has reached 408, with a total of 164 varieties, involving 149 pharmaceutical enterprises; among them, 177 varieties in 289 catalog, with a total of 59 varieties; 90 injection acceptance numbers, with a total of 41 varieties, involving 25 pharmaceutical enterprises Table 1: overview of the undertaking of conformity assessment CFDA has released 5 batches of drugs that have passed the conformity assessment, with a total of 57 items and 29 varieties, including 23 items and 13 varieties in 289 catalogue It is mentioned in the fifth batch of announcement that the varieties that have passed the consistency evaluation of quality and efficacy of generic drugs in the future will be included in the catalogue of drugs on the market in China and will not be announced in batches It can be seen from the query of the catalogue of drugs on the market in China that, in addition to the varieties published in the first five batches, 11 acceptance numbers are newly added at present, reaching a total of 68 acceptance numbers passing the consistency evaluation Table 2: the analysis of the non first five batches of varieties passing the consistency evaluation included in the listing catalog set has been applied for consistency evaluation by enterprises since July 2017 The number of contractors for consistency evaluation in each month is shown in the following figure (calculated according to the acceptance number): At present, a total of 400 consistency evaluation varieties are accepted: Amlodipine Besylate tablets are the most, with 14 acceptance numbers; Amoxicillin Capsules and rosuvastatin calcium tablets are the second, with 12 acceptance numbers According to the acceptance number, rosuvastatin calcium tablets and cefuroxime ester tablets are the most, which are 5 acceptance numbers In addition, 72 varieties have only one acceptance number of consistency evaluation at present If it can be approved quickly, it is expected to be the only variety that has passed the consistency evaluation This part of varieties will occupy an advantage in the bidding process and quickly gain market share Table 3: most popular conformity assessment varieties On the one hand, there have been 5 varieties of consistency evaluation that have reached 3 through enterprise data, including rosuvastatin calcium tablets (the first to reach 3 varieties), amlodipine besylate tablets and montmorillonite, cefuroxime ester tablets, tenofovir dipivoxil fumarate tablets (including a "generic drug approved by new registration classification of chemicals" of Zhengda Tianqing) Table 4: the opinions of the general office of the State Council on the evaluation of quality and efficacy consistency of generic drugs (GBF [2016] No 8) stipulates that the drug varieties passing the consistency evaluation shall be properly supported in terms of medical insurance payment, and medical institutions shall give priority to purchase and clinical use If there are more than three manufacturers that have passed the consistency evaluation for the same kind of drugs, no more varieties that have failed the consistency evaluation will be selected for centralized purchase of drugs At present, a total of 149 enterprise consistency evaluation varieties are accepted, but 75 enterprises have only one acceptance number, more than half of the total number of enterprises At present, Qilu Pharmaceutical Co., Ltd has the largest number of acceptance numbers, reaching 24, plus 12 acceptance numbers of its Qilu Pharmaceutical (Hainan) Co., Ltd and 3 acceptance numbers of Qilu Tianhe Huishi Pharmaceutical Co., Ltd., a total of 39, including 23 injections It can be seen that Qilu pharmaceutical attaches great importance to the consistency evaluation of generic drugs and has strong R & D capacity, only through A little less Secondly, Jiangsu Hengrui has 17 acceptance numbers At present, 29 generic drugs approved according to the new registration classification of chemical drugs are included in the catalogue of drugs on the market in China CFDA has previously pointed out that "generic drugs approved according to the new registration classification are deemed to have passed the consistency evaluation", and the "list of Chinese listed drugs" is of great significance for guiding patients to use drugs - all included drugs are drugs with reliable quality Table 5: generic drugs approved according to the new registration classification of chemical drugs included in the catalogue of Chinese listed drugs are the brief analysis of consistency evaluation varieties, and the data are from the registration and acceptance database of pharmaceutical intelligent drugs and the catalogue of Chinese listed drugs Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; 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