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Multiple injections, has met the conditions of national extraction On May 14, 2020, the State Drug Administration issued a "announcement on the implementation of chemical injection generic drug quality and efficacy consistency evaluation work", marking the official start of the chemical injection consistency evaluation work.
Although the injection consistency evaluation started later than the oral preparation, but due to the large size of the injection market, in the public hospital drug market plays an important role, and participate in the consistency evaluation of the main domestic strength of the head imitation pharmaceutical enterprises, injection consistency evaluation progress has been widely concerned.
GBISOURCE drug database shows that as of November 17, 59 injection products have passed the consistent evaluation, of which ≥ of the three varieties of the evaluation manufacturers, respectively: zuo-laxitan (5), Parexib (4), injection boron tazome (4), albumin yew alcohol (4), ibuprofen (4), ammonia bromoso (3), and sodium pentorazole (3).
In addition, hydrochloric acid right metomide injection, injection with azaside, dosso-tea-alkali injection, iodized par alcohol injection, LOX fluorosa star sodium chloride injection, injection with bivaladin, Glon ammonium bromide injection 7 injection evaluation enterprises are 2, from the full 3 are not far away.
In addition, the Milnet database shows that China Biopharmaceuticals, Hengrui Pharmaceuticals, Qilu Pharmaceuticals, Colum Pharmaceuticals, Yangzijiang Pharmaceuticals Group, Huiyu Pharmaceuticals, Stely, Puli Pharmaceuticals and other enterprises injection consistency evaluation progress is significantly ahead of the industry.
According to Saibai Blue combing, in the current three batches of national mining, a total of 7 injections were included, respectively, the first round of 4 plus 7 band volume procurement: fluorobilofen ester injection, injection with pyrethroids, hydrochloric acid right metomidin injection, second batch of band procurement: injection With yew alcohol (albumin binding type) - the third batch: injection with aza cytosine, left ethyl laxitan injection with a strong solution, hydrochloric acid moxisa star sodium chloride injection, it is worth noting that, among them, fluobilofen ester injection, injection with Pyrethione d'sodium is still only one enterprise evaluation.
that is, the remaining five varieties have a good chance of entering the fourth batch of strip purchases, excluding albumin yew alcohol and lethylene iracetam, which have been incorporated into the collection.
the proportion of injections in the country or increase the national organization of drug collection, the current industry recognized rule is that a variety of competitive pattern reached more than 3, over-evaluated varieties reached dozens, you can carry out volume procurement.
, according to Cypress Blue combing, three batches of state-organized drugs centralized belt procurement, involving a total of 112 varieties, injections only 7.
it is not difficult to see that this is not very consistent with the actual market volume of injections, but also mainly subject to the progress of injection consistency evaluation.
it is expected that more eligible injections will be included in the national scope as the range of drug sets adopted by national organizations continues to expand and injection consistency evaluation is accelerated.
Previously, there has been relevant talk of information - the national collection will be normal, as long as the number of varieties eligible for collection conditions or its amount reached a certain level, that is, trigger the start of national harvesting, is expected to carry out two batches per year;
fact, as early as before the national harvest, injections have become a popular variety of consistent evaluation in many provinces.
According to previous official information from the State Health Insurance Administration, the state supports research and exploration of centralized volume procurement of unestamented drugs and drugs that currently do not have consistent evaluation criteria, such as biological products and Chinese medicines.
for varieties that have not been evaluated consistently, under the guidance of the State Health Insurance Administration, Hebei, Anhui, Fujian, Hubei, Hunan, Guangxi, Qinghai and other provinces have carried out collection of some of the larger drugs.
In recent times, whether it is Henan, Zhejiang, Jiangsu, Shandong, Hubei provincial belt procurement, or Hunan Province, five cities combined belt procurement, or Chongqing, Guizhou Province, Yunnan Province, Guangxi Zhuang Autonomous Region, five provinces (cities, districts) of the belt procurement, are injections as the core collection of reagents.
injections have been popular in the province, such as, Zhuzhou City, Hunan Province, Xiangtan City, Yueyang City, Changde City, Puyang City, five cities combined with the procurement of volume, a total of 20 varieties, only 4 for oral regular release agent type, the remaining 16 are all injections, including: seven-leaf saponin injection, acetylglutylamide injection Injections, omeprazole injections, doso-tea-alkali injections, propofol injections, acetaminophen injections, amphetamine injections, fine-sin brain injections, pythonol injections, inflamed amber injections, toane arginol injections, Ondansjung injections, etc.
Chongqing, Guizhou Province, Yunnan Province, Hunan Province, Guangxi Zhuang Autonomous Region, 5 provinces (cities, districts) of the volume of procurement involving 18 varieties, such as benzoic acid lamine chloroprene, pyridoxine, cephalosporine, pythola Sodium, zucarnitin, hydrochloric acid, growth inhibitors, sodium onnitride chloride, reberazole sodium, melocirin, cephalosporineand tetracycline, etc., are still mainly injection forms.
, Shandong Province, the volume of procurement involving 40 varieties, 27 are injection forms, 13 oral dosage forms, injection type accounted for more than two-thirds.
Hubei Province's first batch of procurement catalogue included a total of 33 drugs, all injectables - involving doso-tea-alkali, fluorooxysaccharides, cycloproxacin, gadysacin, zo-oxyfluorosasacin, amoxicillin, tykaslin, etc., and sartars, xilin antibacterial drugs accounted for the vast majority.
Overall, the provinces and alliances are to select clinically necessary, large clinical use, high procurement amount, adequate market competition for the development of varieties to carry out the criteria for volume procurement, and the frequent list of injections undoubtedly shows its important components in clinical drug use, as well as the urgent need to be included in the collection of realities.
sales of end-drug injections in urban public hospitals, county-level public hospitals, urban community centers and township hospitals in China in 2019 amounted to 636.9 billion yuan, according to the fourth batch of data collected or put on the agenda.
more than 600 billion chemical injection market, provincial-level for varieties that have not been consistent evaluation to carry out collection, the state for the over-consistent evaluation of three varieties to carry out collection is undoubtedly a high probability event.
However, it is worth noting that, according to the statistics of the previous fenge medicine talk, the number of enterprises with 50 varieties, such as Ramif ding tablets, left oxyfluorosa stars, ibuprofen tablets, devasalban tablets, and timishatan tablets, has been evaluated consistently in 3 and above.
, the 50 varieties are still dominated by oral pharmaceutical preparations.
So far, according to combing, a total of 28 provinces and cities have clearly the implementation time of the results of the third batch of national mining, of which 19 provinces and cities have implemented the third batch of national mining, Henan, Shanghai, Xinjiang, Anhui four places will be implemented tomorrow, only Hubei, Tibet, Guangxi has not yet clear specific implementation time, but overall, at the latest, the third batch of national mining should be able to land in the country.
with the full landing of the third batch of national mining, the fourth batch of national mining may be put on the agenda.