State Drug Administration: Aim to complete the backlog of drug registration reviews by 2016

　　For drug registration Review the backlog of serious issues, today (August 18) morning, the State Council issued the "Opinion on the review and approval system of pharmaceutical medical devices" clearly, for the end of 2016 digestion and completion drug registration Application backlog Stock as soon as possible to achieve the annual entry and exit balance of the number of registration applications and reviews, and to achieve approval within the prescribed time limit in 2018 According to the "China Business Daily" reporter sunder-up, the current national backlog of drug review 21,000 pieces in addition, , will speed up the quality consistency evaluation of generic drugs, and strive to complete the national basic drug oral preparations and reference preparations by the end of 2018 consistency evaluation It is understood that this initiative in improving the quality of drugs at the same time, or will increase the price of some drugs it is understood that, in order to encourage research and the creation of new drugs, China will carry out a pilot drug market licensing licensing system, allowing drug research and development institutions and scientific research personnel to apply for registration of new drugs, in the transfer to the production of enterprises, only the production enterprises on-site process verification and product inspection, no longer repeat the drug technical review it is worth mentioning that the time for foreign innovative drugs to enter China will be expected to be shortened, and people will be able to use imported new drugs more quickly digested by the end of 2016 Drug registration Application backlog Stock drug review The backlog is serious and has become one of the biggest obstacles to the development of drug innovation in China in recent years In the view of pharmaceutical companies, the slow evaluation of drugs has seriously affected the innovation enthusiasm of enterprises this year's two sessions of the National People's Congress, the Chairman of Theron Pharmaceuticals, Liu Innovation has complained: "The backlog of materials has exceeded 14,000." Among them, there is no shortage of innovative drugs with independent intellectual property rights These new drugs are slow to market, giving companies a delay in return, which naturally leads to innovation difficulties "
In order to fundamentally solve this problem, the Opinion clearly, will strictly control the market supply of over-demand for drugs approval, and strive to digest the backlog by the end of 2016 Stock as soon as possible to achieve the annual entry and exit balance of the number of registration applications and reviews, and to achieve approval within the prescribed time limit in 2018 Vice Director of the State Administration of Food and Drug Administration Wu Wei introduced at a press conference held by the State Administration of Food and Drug Administration this morning. Drug review The Centre is under review Drug registration A total of 21,000 reviews are now subject to a significant gap between specific review capacity and the actual number of reviews And among them, historical and realistic factors, institutional mechanisms coexist it is understood that our country Drug review Prior to 2000, the review modalities were undertaken by the provinces, and after 2000 the review modalities were reformed, with the central ity of all review powers scattered across the provinces, and the number of reviews increased, but the corresponding personnel did not keep pace, so that the review authority was taken down, Drug review The backlog is always there in Wu Wei's view, the development of pharmaceutical enterprises fast, but the industrial base is relatively weak, low-level repetition phenomenon is more serious and other factors have also caused Drug review The backlog is severe "Our country should say or generic-based country, now we have the hands of the 21,000 varieties, 90% of the generic drugs, more than 80% of the chemicals are generic drugs Now the generic drug inside, the level is not high, the standard is not high, the current law provides that the generic drug is imitation of the existing national standards, so that we think that is imitation standards, the threshold is low, the threshold is low, the declaration volume is large, the declaration volume is large in the process, the repetition rate is particularly serious Wu said frankly and because of the duplicate declaration, also led to a lot of product approvals on the market idle It is understood that the country's pharmaceutical production enterprises now have the approval number is 168,000, but the real products sold in the market, only more than 50,000 approvals, in other words, two-thirds of the approval in "sleep." ", this is a phenomenon, on the one hand surplus products are not produced, on the other hand, there are enterprises continue to declare In essence, this duplication takes up our very limited review resources and the approved products have little market value Wu said in addition, the quality of enterprise declaration is not too high, incomplete information, not true and so on also lengthy review time allow drug research and development institutions and researchers to apply for registration of new drugs
In accordance with the previous laws and regulations of our country, the drug approval number must be approved to the enterprise, which caused a phenomenon: drug developers can only sell products to enterprises, and for the developers themselves, enthusiasm is not high But many researchers do not want to sell products to others, want to carry out their own deep development, so forced the research and development staff to run their own factories, buy bricks to buy equipment.