7 charts in-depth analysis of the progress of the evaluation of the consistency of injections of chemical drugs

Medical Network May 18 hearing on the 14th, the State Food and Drug Administration issued the "Notice regarding the development of chemical injection drug quality and efficacy of generic consistency of evaluation work," which marks the consistent evaluation of drug injection was officially launched!hereby consistency in evaluation of drug injections progress as followsof injection of the drug market is very large, had already issued a document "Collection | article read: Chinese medicine injection of market structure" made a detailed analysisby 2020 April 20, conformance assessment injection CDE hosted the reception number 691, a total of 150 species, involving 153 companies (Figure 1)from October 2018, a first injection Kayaku accepted beginning on the way of rapid growth, the January 2019 has up to 56, due to the occurrence in 2018 December 64 + 7 with a big price cut of the purchase amount exceeds the expected pharmaceutical companies, companies do evaluate the consistency of enthusiasm was frustrated, and later faced with a firm trend in the amount of purchases, companies began to speed up agreement evaluation of speed, the July 2019 peak of 67 admissibilitythis year, due to the impact of new crown epidemic, progress injection conformance evaluation and slow down by December 54 reception number dropped sharply (Figure 2), with the significant mitigation of the epidemic, in particular, yesterday injection conformance assessment released official documents, will set off a wave of injections consistency evaluationUp to now, most admissibility ambroxol hydrochloride injection, the declaration by the 18 pharmaceutical companies, followed by ceftriaxone sodium and omeprazole each sodium 14 (FIG3)off April 17, evaluation of the consistency of injection up to four agents Kelun filed, reception number is 53, the number of species involved is also most, 29 Qilu, Yangtze, China biopharmaceutical 45,37 respectively, after accepting a place, followed (FIG4)Up to now, 41 Kayaku consistency evaluated by injection, wherein the injection ibuprofen up by manufacturers, has 4 by home, paclitaxel (albumin-bound) each have three nanometers by injection, zoledronic acid injections 8 each 2 by injection, sodium chloride injection edaravone 15 different varieties, and the like by aoff March 22, Qilu reception number by the number of consistency in evaluation Kayaku injection up to 43, in the first place, is followed by China Sea 31, SPG 30so far, 4 has been made to expand around + 7,4 + 7 and 3 a second batch of national purchasing with the amount per injection is not absent and no shortage of successful varietieswherein dextromethorphan hydrochloride Yangzijiang pyrimidin-Tropsch injection and when the winning bid to expand around a continuous, cross injectable pharmaceutical Lilly pemetrexed disodium expansion around 4 + 7 + 74 , not in the national health insurance paclitaxel injection directory (albumin-bound) while the new group, and CSPC 3 Henry successful in a second batch with the amount of the purchase"Notice regarding the development of chemical injectiongeneric quality and efficacy evaluation of consistency" will stimulate the release of drug injectionto evaluate the consistency of enthusiasm and sense of urgency, but also indicates the amount of with the advent of a wider range of industry competition, improve concentration and re-shuffle is inevitable.