302 varieties are "advised to withdraw" no longer research and development, declaration!

On September 7, the Chinese Pharmaceutical Society issued the Bulletin on the Release of the Sixth Batch of Over-Repeating Drug Tips, and published the List of Over-Repeating Varieties (Sixth Batch) of More Than 20 Approved Enterprises of the Same Drug, covering 302 varieties, compared with the fifth batch of over-repeating varieties, and a total of 1474 over-repeating drugs were transferred this time compared to the fifth batch of over-repeating varieties.
announcement, the catalog monitors and analyzes the sales of approved drugs for the period 2017-2019, forming the sixth batch of over-repeating drug tips, covering 14 major categories and 60 subsections in the clinical pharmacology and therapeutic classification categories.
It is worth noting that this batch of catalog prompt information added two new contents, based on the Chinese listed drug catalog set, the number of enterprises through the quality and efficacy of generic drugs consistent evaluation of the number of labels, based on the drug approval database, the number of approved enterprises ≤3 dosage forms marked.
01 batch hundreds or even thousands of zombie approval in China's pharmaceutical market, chemicals and biological products varieties in the existence of excessive approved production, there are approved numbers oversupply, low utilization rate phenomenon, the market concentration shows a slow upward trend.
The same variety of finished drugs, if there are more than 20 enterprises in the market in production, will cause unnecessary waste of resources, and this is the Chinese Pharmaceutical Society on the basis of excessive repetition of drugs screening, the same drug approval number of enterprises≥
the relevant person in charge of the Chinese Pharmaceutical Society said that the problem of "stacking competition" of drug varieties should not be ignored, and suggested that pharmaceutical companies should take the initiative to adjust the product structure to achieve high-quality development.
, the market demand for many drugs is saturated or nearly saturated.
From the "catalog" data, the release of 302 kinds of excessive repetitive drugs to see, Amni near, compound sulfonamide methamphetamine, acetaminophen, vitamin C, glucose, methazole and other 6 kinds of drugs have thousands of approvals, respectively, 1275, 1284, 1301, 1092, 1874, 1839, 1162;
the list, you can also see that 302 drugs, whether in pharmacies or hospitals in the end-market, their market share of 70% to 90% are in the top 10 sales of enterprises.
With regard to the situation of thousands of batches of the same drug, experts believe that this is related to the over-declaration of drug varieties in the past, drug approvals can generally be re-registered every five years, re-declaration requirements and costs are lower than newly obtained approvals.
industry sources said that usually the same drug can be different manufacturers, drug specifications, dosage forms will have different approvals, but many enterprises do not produce drugs do not write off the approval, so there are many "zombie approvals."
To the example of methazole, which has the approval number of 797 enterprises, of which a considerable number of enterprises have not produced or sold the drug, but in order to retain the production line for future production needs, enterprises will not take the initiative to cancel the approval.
02 consistent evaluation or will alleviate the pile production of this catalog of new "over-evaluation of the number of enterprises" and "approval of the number of enterprises≤3 dosage form label" two major statistics, is undoubtedly the biggest bright spot.
the industry, consistent evaluation may alleviate the problem of severe overcapacity and over-reuse of medicines.
consistent evaluation to promote generic drugs in clinical substitution of original research drugs, improve the quality of generic drugs in China and the overall level of development of the pharmaceutical industry on the basis of the phenomenon of excessive drug duplication has been alleviated to a certain extent, drug homogenization of the obvious momentum to a certain extent to contain.
In accordance with the "same varieties of drugs through the consistent evaluation of the production enterprises reached more than 3, in the centralized procurement of drugs and other aspects no longer choose the varieties without consistent evaluation" requirements, a large number of generic drugs that did not pass the consistent evaluation, will undoubtedly be kicked out of the market to face elimination, pre-imitation, low-cost competition of the vicious situation will be effectively controlled.
of the 302 over-repeating varieties, only 67 have been evaluated by enterprises;
03 To guide enterprises to adjust their research and development strategy, it is understood that the purpose of formulating an over-repeating catalogue is mainly to prompt research and development institutions to adjust research and development decisions, reduce or even stop the registration applications of over-repeated varieties, and to realize the transfer of drug review and approval resources to innovative drugs and first imitation drugs.
at the same time prompt production enterprises to adjust production decisions, in order to maintain the quality of drugs and ensure the supply of the premise of healthy market competition.
as a reference for scientific arrangement of industrial and product restructuring, to guide the pharmaceutical industry to improve concentration, accelerate industrial transformation and upgrading to achieve high-quality development.
as a scientific reference to determine the "classified procurement" method, guide the centralized procurement of drugs, to ensure the supply of drugs.
past five years, the state has been strengthening supervision of the over-repetitive drug market.
the Chinese Pharmaceutical Society's continuous "Overdrive Drug Catalog" is a signal.
The Chinese Pharmaceutical Society, commissioned by the State Drug Administration, has published a catalogue of information on over-repetitive drug tips, and tens of thousands of drug approval numbers have been written off in the past two years.
There is also a view that relevant departments should continue to improve the drug registration information release system in accordance with the drug registration approval situation, effectively guide drug research and development projects and topics, limited resources to innovative drugs with clinical value and clinical urgent need for generic drug review and approval tilt, to avoid a large number of repeated research and development and waste of resources.