2020 consistency evaluation speed up? Injections become the main force

TextsWhen thetime wheel turn, the extraordinary 2020 has been quietly half, affected by the epidemic, the rate of progress of the work is relatively slow, however, over time, the matter gradually warmed up, consistency evaluation work is no exception, according to the drug registration and acceptance database shows that as of June 5, CDE consistency evaluation acceptance number reached 2090 (551 enterprises 506 varieties, according to supplementary applications) Although the consistency evaluation work has been advancing, but in March and April the number of acceptances fell sharply, is less than half of the total in February, in May gradually warmed up 70 acceptance numbers were hosted, the details are as follows:is worth mentioning is that in May the State Drug Administration issued "to carry out chemical injection generic drug quality and efficacy consistency evaluation of the announcement", announced that the injection consistency evaluation officially began; The three documents of the "Requirements for the Reporting Of The Quality and Efficacy Consistency Evaluation of Chemical InjectionS" and the Technical Requirements for the Evaluation of the Quality and Efficacy Consistency of Generic Drugs in Chemical Injections (Special Injections) indicate that the evaluation of injection consistency will be comprehensively promoted, or will be the focus of the consistency evaluation work in the coming periodAs of June 5, 739 injection acceptance number declaration consistency evaluation, in May a total of 47 enterprises 51 varieties of declaration consistency evaluation was accepted, of which, from the dosage form, injections as the main target of the declaration, accounting for 58.57 percent (powder injection 42.86 percent, injection 15.71 percent)Among them, may layout injection consistency evaluation of the enterprises are not short of Zhengda Qing, stone drug Ouyi, Kazakhmedicine, Yichang Peoplefu and other well-known enterprises, of which 3 enterprises were accepted in one breath two heavy injections, Yichang Manfu's fluoromani injection and rosacea metolol injection, Baiyun In addition, there is a variety of two enterprises competing to declare the injection of cephalosporine sodium and injectable cephalosporine sodium, Mesobamo injection of Jiangsu Wu Traditional Chinese Medicine and lansozoin for injection, in addition, there is a variety of two enterprises competing for the injection of Nanjing Zhengda Tianqing and Suzhou Terry PharmaceuticalsMay injection consistency evaluation declaration acceptance details
the first evaluation of more than 1 billion varieties, there is no shortage of more than 1 billion varieties
, so far, the cumulative 572 acceptance numbers through the consistency evaluation (according to supplementary applications), of which 17 acceptance numbers in May 13 varieties have been Evaluation, which has 6 product rules for the first review, 2 varieties successfully formed a three-legged trend, in addition to hydrochloric acid metformin 0.25g specifications of the evaluation of enterprises up to 23, Catopuri film evaluation enterprises broke 10, the degree of competition can be imaginedMay consistency evaluation of the details of the table
it is worth mentioning is Qilu Pharmaceutical's Isimetan tablets, Fosun Pharmaceuticals subsidiary Shanghai Chaoyu Pharmaceuticals' Bicaruamine tablets, both varieties are the first in May to be evaluated the heavy varietiesaccording to pharmaceutical data, 2019 Isimetan tabletdomestic sample hospital sales of 127 million yuan, of which the original research Pfizer accounted for the main market share, 67.22%;According to the latest IQVIACHPA data, in 2019, The sales of Bicaruamine tablets in China is about RMB1.23 billionAccording to the sales data of the hospital, the largest share of the sample hospital stake was AstraZeneca, which reached 80.36 percentLike Qilu Pharmaceuticals' Isimetan, it will further enhance its competitiveness and will challenge the original research and development to obtain more profitsMay in addition to the approved drugs, there are 4 varieties approved, will be evaluated, the specific details can be seen in the following table:May consistency evaluation approval details
with the continued in-depth promotion of band procurement, through consistency evaluation is a ticket for generic drugs is an indisputable fact, consistency evaluation is a good time to reshape the market pattern Now China's epidemic has been effectively controlled, all matters are steadily forward, consistency evaluation work continues to accelerate, especially after the comprehensive evaluation of the consistency of chemical injections, do it quickly, do a good variety will stand out! attached: This week (May 29 to June 5) consistency evaluation evaluation and declaration acceptance details form
this week's consistency evaluation evaluation details form this week's consistency evaluation declaration acceptance details table