There is still room for a large-scale list of over-repetitive drugs

In mid-September, the CFDA issued an over-repetitive drug alert notice. According to the number of approved enterprises more than 20 and the number of enterprises in the sale of more than 20 for screening conditions, including methotrexazole, glucose, vitamin C, Loxyfluoxacin, erythromycin, ibuprofen, aspirin, amosillin and other 282 excessively repeated varieties were included in the catalogue, many of which are commonly used drugs.
noted that this is not the first time that authorities have published catalogues of over-repeated medicines. In August 2012, the Center for Drug Review issued the "Antimicrobial Generics in Review Of Varieties", listing 25 varieties of antimicrobial drugs with large repeat declarations. In September and November 2014, the State Food and Drug Administration screened and published a catalogue of over-repeated drug varieties in two batches based on the number of drug approval numbers and the number of registration applications.
" companies must note that the catalog was published in the context of generics consistency evaluations. Dr. Chen Wei, a researcher at the Drug Policy and Management Research Center of Huahua University of Science and Technology, told the Journal of Pharmaceutical Economics that since this part of the generic drug varieties belong to the new symbol rather than the stock number, it is not ruled out that the future may be similar to the previous generic drug evaluation requirements, as the same varieties up to more than 3 through the consistent evaluation, in centralized procurement and other aspects of the selection of unexisted varieties.Common common drugs on the list
"Pharmaceutical Economics" reporter noted that the list of the whole body with anti-infectant drug compound sulfonamide methamphetamine has been approved the number of 1343, has been approved the number of enterprises 1009;
And in the sample hospital, the combing of the mine network shows that of the 282 products released this time, the largest number of approvals are glucose, 828 are in sale, involving 188 enterprises in the sale; 57 approvals, involving 181 enterprises in sale, more than 300 products in the sale of approval are azithromycin, Loxyfluoxacin and sodium glucose chloride, these three products involved in the sale of more than 100 enterprises.
" sales amount of the top 10 varieties, its total sales of more than 90% of the total sales amount of this variety has 2088, accounting for 93.17% of the total; Explain that the same variety has 10 enterprises production and sales can basically meet market demand. "The CFDA data are clearly suggested.
" market concentration seems to be very high, the same variety actually does not need so many manufacturers to produce. A pharmaceutical industry source pointed out, "In the current bidding situation, to ensure a certain degree of concentration of drugs, is conducive to enterprises to obtain relatively reasonable profits, manufacturers do not have to low-cost vicious competition."
According to the signal disclosed in the announcement, Shenzhen Xinlitai Pharmaceutical Co., Ltd. Deputy General Manager, head of research and development Yan Jie predicted: "The future may be more than a certain number of the same product declaration (such as 10) on the prompt for over-declaration, different products may be different, this measure will also be improved in the implementation." " Directory guidance role geometry
Another focus is that, because the catalog is not clear, for the current research and development and declaration process of excessive duplication of drugs, the State Administration of future approval will take attitude, catalog release can effectively guide enterprises to carry out research and development restructuring, priority research and development of innovative drugs with clinical value and clinically urgently needed drugs?
, the significance of publishing the catalog is not administrative intervention, because research and development is more of a market action. The document is only macro guidance recommendations, enterprises need to according to the guidance, to decide which varieties to develop.
, however, it is important to note that since corporate research and development is autonomous, decision-making takes into account multiple factors such as market, supply and innovation direction, and takes risks accordingly. Similar research and development also has consistency problems, such as when it comes to comparison between references, process consistency, prescription consistency and other issues, whether a variety is worth research and development, declaration, production, and after the market to face what market tests, all need to be assessed by the enterprise itself.
Yanjie holds a similar view:
National No. 44 and a series of subsequent documents emphasize to guide enterprises to make reasonable and orderly declarations, the release of the directory more significance is to remind and guide." In fact, the major pharmaceutical companies in the research and development decision-making will do relevant research, will not affect the enterprise project. " over-repeating varieties can still be
from a statistical point of view, "zombie approval" situation is serious. "Pharmaceutical Economics" reporter found that the catalog approved thousands of compound sulfonamide methamphetamine market shortage, was included in the National Health and Planning Commission Drug Policy and Basic Drug System Division issued the "2016 clinical necessities, small dosing, market supply shortage of drugs fixed-point production enterprises tender announcement."
addition, China's drug research and development dilemma is also, in the excessive research and development of some commonly used drugs at the same time, independent research and development of new drugs less, orphan drugs less, children with less drugs.
" commonly used drugs themselves require lower technical requirements, less investment in research and development, and do not need too much time and cost to do market cultivation. In addition, even over-repeated varieties may still make a profit in a given region. One medical researcher pointed out.
enterprises will also fully assess the risks of doing innovative drugs, orphan drugs, children's drug research and development. Due to the long domestic access time for new drugs, combined with the direction of drug tender procurement evolution, leaving a relatively small space for innovative drugs, although some provinces have some additional or special channels to allow new drugs to enter, but the overall proportion is limited. According to Chen's analysis, the current rapid growth of medical costs, drugs are difficult to occupy more resources for health care and health costs, so the general trend is to do structural optimization in the stock, rather than large-scale integration of innovation, incentive innovation, but only a few innovation.
" common large varieties, more declared enterprises, we can all get a piece of the pie. Yan Jie told the Medical Economics Daily, but as the country's requirements become more stringent, research and development costs increase, the survival of the fittest will accelerate, the situation of push declaration will be eased. Whether the research and development dilemma of orphan drugs and children's medicine can be improved depends on whether there are corresponding policies, such as giving these varieties a longer protection period, so as to ensure that pharmaceutical companies can obtain a certain profit, so that research and development investment is in a positive ratio. (Medical Economics)