2020 consistency evaluation speed up? The injection is the main force.

The turn of the wheel of time, 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 of 2090 (5) 51 enterprises 506 varieties, according to supplementary applications), since the outbreak of the new crown 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 on the Evaluation of the Quality and Efficacy of Chemical InjectionS" and announced the official start of the evaluation of injection consistency. The three documents of the requirements for the declaration of the quality and efficacy consistency evaluation of generic drug injections in drug 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 period.
, on June 5, 739 injection 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 declared object, accounting for 58.57 percent (powder injection 42.86 percent, injection 15.71 percent).
May consistency evaluation declaration dosage form ratio map Of the May layout injection consistency evaluation of enterprises no shortage of positive day, stone medicine European-Italian, ha medicine, Yichang people Fu and other well-known enterprises, of which 3 enterprises were accepted in one breath two heavy injection declaration, Yichang people Fu's flumasini injection and rosacea acid Tolor injection, Baiyunshan injection of cephalosporine sodium and injection of cephalosporine sodium, Jiangsu Wu Traditional Chinese medicine mesobamo injection and injection of lansoola, in addition, there is a variety of two enterprises competing to declare, for Nanjing Zhengda Tianqing and Suzhou Teri Pharmaceuticals injection of boron-to-zomi.
May injection consistency evaluation report acceptance details The first evaluation of multiple varieties, there is no shortage of more than 1 billion varieties, so far, the cumulative 572 acceptance numbers through consistency evaluation (by supplementary application), of which 17 acceptance numbers in May 13 varieties have been evaluated Among them, there are 6 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 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, 2019 Isimetan tablet domestic 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 Bircaruamine tablets in China is about RMB1.23 billion.
, according to pharmaceutical hospital sales data, the largest share of sample hospitals is AstraZeneca, up 80.36 percent.
, like Zilu Pharmaceutical's Isimetan, further enhance its competitiveness and will challenge the original research and development to obtain more profits.
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 continuous in-depth promotion of tape procurement, through the consistency evaluation is a ticket for generic drugs has been an indisputable fact, consistency evaluation is a good time to reshape the market pattern.
the current outbreak in China has been effectively controlled, the matters are steadily forward, consistency evaluation work continues to accelerate the promotion, especially after the comprehensive evaluation of the consistency of chemical injections, do a fast, well-done varieties will stand out! Attached: This week (May 29 to June 5) consistency evaluation evaluation and declaration acceptance details table This week consistency evaluation evaluation details table This week consistency evaluation report acceptance details table (Note: red font for this week's new acceptance varieties) data source: drug intelligence data, corporate announcements and other network public data sources: drug intelligence network, corporate announcements and other network public information.