Medical network on March 23 - March 22, the ministry officially issued by the consumer goods industry "2017" doctrine of "special plan of action to notice" (hereinafter referred to as the "notice"), notification requirements from increasing variety, quality, creates the brand, and optimum environment four aspects to strengthen quality management and standard system construction, the influence of the "China brand".
As early as June 2016, general office of the state council has issued by the implementation of consumer goods industry "the doctrine of" special action to create a good market environment to several opinions, deployed to carry out the consumer goods industry increasing variety, quality, creates the brand "the doctrine of" special operation. Some experts said the notice issued by the ministry is to further implement the several opinions of the state council, also suggests that "the doctrine of" special action plan entered the stage of fall to the ground.
Notable is that the printed notice mentioned encourages the development of over-the-counter (OTC) drug, promote to speed up the shortage of domestic urgent clinical needs, market drug approval for examination and approval.
The Beijing minister, head of the medical management consulting center Shi Lichen an interview with the daily economic news "reporter said, for now, our country on drug approval for examination and approval of the review, especially the shortage of medicine efficiency is not high enough, leading to serious backlog of drug approval contradiction. "Shorten the approval time, improve the efficiency of examination and approval, is not only beneficial to relieve the contradictions of backlog, more conducive to innovation and application of drugs."
Focus on the formation of a batch of branded generics
Notice requires that the future will promote the innovation in medicine high-end preparation and green manufacturing center construction, cultivation of generic drug varieties, forming a batch of branded generics. To speed up the research and development and production of new drugs, promote to speed up the shortage of domestic urgent clinical needs, market drug approval for examination and approval.
Jingquan, head of the national food administration of drug safety, Feb. 27 in the scio said at a news conference, Chinese drug review of medical equipment examination and approval system reform for more than a year, the national drug review staff number increased by 4 times, backlog of registration number fell by more than sixty percent, this year will continue to increase the review staff, solve the contradictions of the backlog in an all-round way.
Jingquan, since August 2015, state the number of drug approval personnel from 120 to 600, two years ago, meanwhile, has registered a number of the backlog of applications from 2015 at the peak of 22000, to around 8000 now.
In Shi Lichen point of view, to speed up the innovation and development in the field of medicine, in addition to improve the efficiency of review for examination and approval, also need to attach importance to cultivate and improve the branded generics.
"To lower drug prices as soon as possible, let the people to use, reliable quality, cheap price," life-saving medicine ", and authorized copy is the safest and most desirable way. So far, our country already has more than 40 brands of generics successfully into the overseas, and have a good performance. But generics in domestic are not perfectly realize the replacement of imported drugs, in addition to the affected by the doctor prescribing habits, is a very important reason why patients for generic drugs is still a lack of confidence." Shi Lichen said.
Perfect the multidisciplinary standard evaluation system
The printing in the notice, in intelligent manufacturing, food and drug, household appliances and other fields are referred to accelerate the relevant industry standards and enterprise standards. Generic drugs, for example, in March 2016, national food drug safety administration has issued by the opinion, delimit the 289 generic drugs kind of consistency evaluation finished at the end of 2018.
Shi Lichen thinks, "the doctrine of" issued by the ministry of industry and consumer goods industry specific plan of action, suggests that the government's determination and confidence. "In terms of medical field, and perfect the standard evaluation system to establish the credibility of domestic branded generics, but also to relieve the contradictions of the depth of field of generic drugs are of variable quality."
Reporter discovery, the printed notice in addition to continue to promote "the doctrine of", is also a more continue to push forward "environment". In this part, involving use of special construction funds support eligible consumer goods manufacturing enterprises to carry out the strategy of "doctrine", and strengthen consumer goods "the doctrine of" project sites and WeChat construction.
In June 2016, the then ministry vice-minister feng fei in the ministry of industry and the media briefing said when reading strategy of "doctrine", implement the strategy of "the doctrine of" consumer goods industry, is to promote the supply side structural reform, promote the steady growth of industrial and construction of the important measures of manufacturing power. "Our ministry is planning to use the funds to set up the consumer goods industry transformation and upgrading of industrial 'doctrine of' special, fund size of hundreds of millions of yuan, is currently studying formulate implementation plan." |