Injection over-evaluation drama debut tender procurement is facing a life-and-death situation.

On May 14, the official website of the State Drug Administration issued the "Announcement of the State Drug Administration on the evaluation of the quality and efficacy of generic chemical injections", which formally requires that generic drugs with chemical injections that have been listed should be evaluated for consistency in any variety that has not been approved in accordance with the principle of consistency with the quality and efficacy of the original drug.
the holder of a drug market license shall select the reference formulation in accordance with the List of Generic Drug Reference Preparations issued by the State Drug Administration and carry out a consistency evaluation and research and development declaration.
According to the relevant data, the total number of injections is currently nearly 33,000, but so far only 41 injection products have passed/seen through consistency evaluation.
, some enterprises have been in the "4 plus 7" band procurement and national collection of the first.
2018, China's public medical institutions terminal chemical drugs and Chinese traditional drugs total sales of 692 billion yuan, of which, chemical injections accounted for more than 85%.
understand that from the market size, china's chemical market size in 2019 642.3 billion yuan, of which injections accounted for 57%.
relatively competitive varieties of chemical injections (sales enterprises s 3) accounted for 56% and sales accounted for 18%.
According to the relevant reports of the pharmaceutical Rubik's Cube, from the reference preparation, China has announced that there are 257 varieties of injections of reference preparations, accounting for only 20% of the total injection varieties, and 80% of the United States reference preparations have not been included in the chinese reference preparation stake.
in the already analogy of the injection, there are 33 varieties are not currently listed manufacturers, 34 varieties are currently listed or DMF status a raw material stylist.
in fact, pharmaceutical production enterprises pay great attention to the reasons for injection, nothing but because of the import volume of procurement reasons.
from the national point of view, three batches of two rounds of national belt procurement is basically oral preparations, the reason is that on the one hand, the injection has not yet clear rules, on the other hand, the injection itself is controversial, the National Drug Adverse Reaction Monitoring Center issued adverse reaction monitoring report shows that 2011-2017 China's Chinese medicine injection adverse reactions accounted for more than half of the adverse reactions of Chinese medicine, in 2017 accounted for 54%.
and the causes of adverse reactions of Chinese medicine injections are mainly distributed in the production and use of the production and use, the quality of raw materials can not be guaranteed, the preparation and production backward, the enterprise production process GMP problems, overdosing use, drug evidence does not match, the use of dissolved media unreasonable, Chinese and Western medicine mixed, etc. ;
from the point of view of provincial-level volume procurement, on March 5, the State Council of the Central Committee of the Communist Party of China issued the Opinions on Deepening the Reform of the Medical Security System, which explicitly requires that, by adhering to the combination of recruitment and price-to-price, and the full implementation of centralized volume procurement of pharmaceutical and medical supplies.
on the basis of medical insurance payment, establish a provincial tender and procurement platform for bidding, procurement, transaction, settlement and supervision, and promote the construction of a regional and national alliance procurement mechanism to form a fully competitive, reasonably priced and standardized and orderly supply security system.
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in accordance with the implementation plan announced by Shanxi Pharmaceutical Mining Center, all medical institutions in the province's medical institutions drug supplies procurement alliance will participate, other medical insurance designated social medical institutions can voluntarily participate.
this is also the first time that there is a provincial drug procurement platform dedicated to the injection varieties.
, according to the documentation requirements, the purchase volume for the 2019 procurement alliance medical institutions in one year selected products and generic drugs Shanxi Province platform total procurement volume of 70%.
the procurement volume here, does not distinguish between the original research, generic drugs, but in the name of the same generic name for statistics, from this point of view, this 70% of the amount is a comprehensive calculation of all the original research generic drugs tied calculation, as for the other 30% of the amount, estimated to be not selected but selected in the provincial standard of the varieties.
comprehensive above-mentioned factors is not difficult to see, from the national level and provincial and municipal level, when the consistency evaluation of this key factor, the volume of procurement will become particularly simple, through the recruitment of price reduction, further pressure to suppress the relevant price moisture, drug band procurement will officially enter the "national mining and provincial mining" division of the new stage of the siege, coupled with the special safety of injectionites itself, the combination of fists to the meat, will be punched to the meat.
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