2020 consistency evaluation speed up? Injections become the main force
Last Update: 2020-06-17
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Pharmaceutical Network June 9th, the time 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 mattergradually 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 of 506 varieties, according to supplementary applications), since the outbreak of the new crown outbreak in February, the consistency evaluation work has been advancing, but in March and April the number of acceptance sharply reduced, is less than half of the total in February, May gradually warmed up 70 acceptance numbers were hosted, the details are as follows:injection consistency evaluation has become the main theme?It is worth mentioning that in May, the State Drug Administration issued the "announcement of the evaluation of the quality and efficacy of generic drugs for chemical injections", announcing the official start of the evaluation of injection consistency, and on the same day, the National Drug Review Center issued the Technical Requirements for evaluation of the quality and efficacy of chemicaldruginjection simulu suppial drugThe three documents of the requirements for the declaration of the quality and efficacy consistency evaluation of generic drug injections 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 the consistency of injections 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)May consistency evaluation declaration dosage form ratio map
which May layout injection consistency evaluation of enterprises no shortage of good-known enterprises such as Zhengda Qing, stone medicine Ohi, Ha medicine, Yichang Peoplefu, of which 3 enterprises were accepted in one breath two heavy injections, Yichang people Fu's flumasini injection sinfy and rosacea metolol Injection, Baiyunshan injection of cephalosporine sodium and injection of cephalosporine sodium, Jiangsu Wuzhongpharmaceuticalmesobamo injection and injection of lansoola, in addition, there is a variety of twoenterprisesto declare, for Nanjing Zhengda Qingqing and Suzhou Teri Pharmaceuticals injection of boron-to-zomiMay injection consistency evaluation declaration acceptance detailsthe first evaluation of more than 1 billion varieties, there is no shortage of more than 1 billion varieties in theso far, the cumulative 572 acceptance numbers through the consistency evaluation (by supplementary application), 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 imagined May consistency evaluation of the details of the table
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 varieties According to pharmaceutical data, in 2019, the domestic sample of Thei Metin tablets hospital sales of 127 million yuan, of which the original research Pfizer account
ed for the main market share, 67.22%; According to the latest IQVIACHPA data, in 2019, the sales of Bircaruamine tablets in China is about RMB1.23 billion According to the sales data of the hospital, the largest share of the sample hospital stake was AstraZeneca, which reached 80.36 percent Like Qilu Pharmaceuticals' Isimetan, it will further enhance its competitiveness and will challenge the original research and development to obtain more profits In May, 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 has been 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 (Note: red font for this week's new acceptance varieties) data sources: drug intelligence data, enterprise announcements and other network public data source of information: drug intelligence network, enterprise announcementand and other network public information
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