"Three products" action plan landing, short drug approval will be speeded up

Source: Medical Network March 23, 2017 Pharmaceutical network March 23 March 22, the Ministry of industry and information technology officially issued the "2017 consumer goods industry 'three products' special action plan notice" (hereinafter referred to as the "notice"), which requires comprehensive strengthening of quality management and standard system construction from four aspects: increasing variety, improving quality, creating brand and excellent environment, so as to create the influence of "Chinese brand" As early as June 2016, the general office of the State Council issued several opinions on carrying out the special action of "three products" in the consumer goods industry to create a good market environment, and deployed to carry out the special action of "three products" in the consumer goods industry to increase variety, improve quality and create brand Some experts said that the circular issued by the Ministry of industry and information technology is the further implementation of several opinions of the State Council, and also shows that the "three products" special action plan has entered the stage of implementation It is worth noting that the notice specially mentioned encouraging the development of over-the-counter drugs (OTC drugs) and accelerating the review and approval of drugs in urgent clinical need and market shortage in China Shi lichen, head of Beijing Dingchen medical management consulting center, told the daily economic news that at present, the efficiency of drug review and approval, especially the approval of drugs in short supply, is not high enough in China, which leads to a serious backlog of contradictions in drug approval "To shorten the approval time and improve the approval efficiency is not only conducive to easing the backlog of contradictions, but also conducive to the innovation and application of drugs." Efforts will be made to form a batch of brand generic drug notice requirements In the future, we will promote the construction of high-end pharmaceutical and green manufacturing innovation center, cultivate large varieties of generic drugs, and form a batch of brand generic drugs We will speed up the research and development and production of new drugs, and accelerate the review and approval of drugs that are urgently needed in clinical practice and are in short supply in the market Bi Jingquan, director of the State Food and drug administration, said at a press conference held by the new China food and Drug Administration on February 27 that the number of national drug reviewers has increased fourfold in more than one year since the reform of China's drug and medical device review and approval system, and the backlog of registration applications has dropped by more than 60% This year, the number of reviewers will continue to increase to comprehensively solve the backlog contradiction Bi Jingquan said that since August 2015, the number of national drug reviewers has increased from 120 two years ago to 600 At the same time, the backlog of registration applications has dropped from 22000 at the peak in 2015 to about 8000 at present In his view, to speed up the innovation and development of the pharmaceutical field, in addition to improving the efficiency of review and approval, we need to pay attention to the cultivation and improvement of brand generic drugs "If we want to reduce the price of drugs as soon as possible, and let people use" life-saving drugs "with reliable quality and low price, authorized imitation is the safest and most desirable way Up to now, more than 40 brands of generic drugs have successfully entered the overseas market and achieved good results But in China, generic drugs do not replace imported drugs very well Apart from the influence of doctors' prescribing habits, a very important reason is that patients still lack confidence in generic drugs " Shi lichen said In the notice of improving the multi field standard evaluation system issued this time, it was mentioned to accelerate the formulation of relevant industry standards and enterprise standards in intelligent manufacturing, food and drug, home appliances and other fields Taking generic drugs as an example, in March 2016, the State Food and Drug Administration issued opinions to designate 289 generic drugs to complete the consistency evaluation by the end of 2018 According to Shi lichen, the Ministry of industry and information technology issued the "three products" special action plan for the consumer goods industry, which shows the determination and confidence of the government "In the field of medicine, improving the standard evaluation system is conducive to establishing the credibility of domestic brand generic drugs, as well as alleviating the deep-seated contradictions of uneven drug quality in the field of generic drugs." The reporter found that in addition to continuing to promote the "three products" in the notice, there is also an additional "excellent environment" to continue to promote In this link, it involves using special construction funds to support qualified consumer goods manufacturers to implement the "three products" strategy, as well as strengthening the construction of consumer goods "three products" special website and wechat In June 2016, when Feng Fei, then Vice Minister of the Ministry of industry and information technology, interpreted the "three products" strategy at the media conference of the Ministry of industry and information technology, he said that the implementation of the "three products" strategy of the consumer goods industry is an important measure to promote supply side structural reform, promote stable industrial growth and build a manufacturing power "Our department is planning to use the funds for industrial transformation and upgrading to set up the" three products "special project for consumer goods industry, with a capital scale of several hundred million yuan, and is currently studying and formulating the implementation plan."