There are more than 300 acceptance numbers of generic drug consistency!

As of August 17, 2018, the acceptance number of conformity assessment undertaken by CDE has reached 311, with a total of 139 varieties; of which, there are 136 acceptance numbers of 289 catalog varieties, with a total of 52 varieties There are 60 injection acceptance numbers, 30 varieties in total CFDA has released 5 batches of drugs that have passed the consistency evaluation, with a total of 57 drugs and 29 varieties, including 23 drugs and 13 varieties in 289 catalogue The fifth batch of announcement mentioned that: in order to further improve the work efficiency, the drug evaluation center of the State Food and drug administration shall timely receive and record the varieties that pass the quality and efficacy consistency evaluation of generic drugs after this announcement into the catalogue of Chinese listed drugs for real-time reference by the industry, the public and relevant departments, and our bureau will not make announcement in batches It can be seen from the query of the list of drugs on the market that, in addition to the varieties published in the first five batches, 6 product specifications have been published and passed the consistency evaluation In addition to the information disclosed by enterprises in the near future, 64 acceptance numbers have passed the consistency evaluation, and another 9 acceptance numbers have failed to pass the consistency evaluation Table 1: since July 2017, the non first five batches of conformity evaluation varieties included in the listing catalogue set have successively applied for conformity evaluation by enterprises, with an average of 12 in 2017 and 30 in 2018 It peaked in June 2018, with 59 The number of application for conformity assessment in each month is shown in the figure below (calculated by acceptance number): in terms of varieties, 311 conformity assessment varieties have been accepted; amlodipine besylate and rosuvastatin calcium tablets currently have a maximum of 12 acceptances The second is montmorillonite powder and amoxicillin capsule, the acceptance number of consistency evaluation is 9 Table 2: in terms of the most popular consistency evaluation varieties, there are three varieties that have passed the enterprise data, including rosuvastatin calcium tablets, amlodipine besylate tablets and montmorillonite powder In addition, some "generic drugs approved according to the new registration and classification of chemical drugs" are included in the catalogue of Chinese listed drugs, such as tenofovir dipivoxil fumarate tablets of Zhengda Tianqing, which are deemed to have passed the consistency evaluation and reached the tripartite confrontation According to the opinions of the general office of the State Council on the evaluation of the consistency of quality and efficacy of generic drugs (GBF [2016] No 8), the drug varieties through the consistency evaluation shall be properly supported in the payment of medical insurance, and the medical institutions shall give priority to purchase and use them in clinical practice 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 According to the bidding policies of each province, consistency evaluation has many advantages In addition, several varieties have already passed the consistency evaluation of two enterprises, which is about to form a tripartite confrontation Table 3: in terms of enterprises with two consistency evaluation varieties, 126 enterprises have accepted the consistency evaluation varieties, but 67 enterprises have only one acceptance number At present, Qilu Pharmaceutical Co., Ltd has the largest number of acceptance numbers, up to 19, plus its eight acceptance numbers of Qilu Pharmaceutical (Hainan) Co., Ltd., a total of 27 It can be seen that the enterprise has a more positive evaluation of consistency, but only a little less in terms of passing Secondly, Jiangsu Hengrui has 15 acceptance numbers Huahai pharmaceutical industry is undoubtedly the biggest winner, and all 10 acceptance numbers have passed the consistency evaluation Chongqing Yaoyou also performed well, with 7 acceptance numbers and 2 have passed Top 10 pharmacology types of consistency evaluation enterprises (by varieties) at present, among the 139 consistency evaluation varieties undertaken by CDE, the most anti infective drugs for the system are up to 30, including Amoxicillin Capsules, cefuroxime axetil tablets, ceftriaxone sodium for injection and other drugs Secondly, there are 22 nervous system drugs The pharmacological types are shown in the following figure: