The time point for consistency evaluation is approaching generic drugs to promote the reshuffle of the preparation industry

2013-12-18 source: China Securities Network reporter learned that "by the end of this year, the country will complete the consistency evaluation of 75 generic drugs, and comprehensively improve the quality and safety standards of drugs." This is the latest news on the spot that the pharmaceutical research and development industry committee of China Association of foreign funded enterprises released the report "analysis of main factors affecting differences in drug quality" in Shanghai According to a reporter's investigation, after the results of the consistency evaluation of generic drugs are released, those with excellent quality and effect of generic drugs can narrow the price gap with imported original research drugs, and more easily enter the medical insurance and bidding system of all regions, and those who fail to pass the evaluation will be delisted It can be said that the consistency evaluation of generic drugs will promote the overall "reshuffle" of the chemical pharmaceutical industry, which is good for companies with strong R & D technology and integrated producers of raw materials and preparations, such as Hengrui pharmaceutical, Huahai pharmaceutical, modern pharmaceutical, etc According to Chen Zhefeng, senior consultant of Qinmai pharmaceutical consulting Co., Ltd., 94.7% of China's current listing licenses of more than 189000 drugs were issued before the implementation of the new measures for the administration of drug registration in 2007, which is far lower than the current approval standard for going to the market Therefore, February 13, 2012 The 12th Five Year Plan for national drug safety was issued by the State Council on February, which clearly requires that generic drugs approved before the implementation of the administrative measures for drug registration revised in 2007 should be evaluated for quality consistency with generic drugs by stages and batches, and "supplementary lessons for history" should be carried out However, it is also a huge challenge to complete this task: the United States launched bioequivalence evaluation in 1971, which lasted for 10 years and eliminated 6000 drugs; Japan launched "drug quality re evaluation project" in 1997, which has completed about 730 drugs so far To complete the reevaluation of more than 100000 generic drugs in China and solve such a heavy historical burden, the State Food and Drug Administration (CFDA) has a huge pressure on human resources and technical reserves, and its difficulty and time can be imagined China's drug quality improvement faces historic opportunities Low quality drugs have a huge cost advantage over high-quality drugs When regulatory standards allow the existence of such low-quality products, enterprises often lack the motivation to improve the quality According to Shanghai's 2007-2009 According to the comparative analysis of the data of imported drugs and local sampling drugs in the same period, the overall unqualified rate of imported drugs was maintained below 0.1%, and that of domestic preparations was about 3%, nearly 30 times higher "Only by continuously upgrading GMP and other drug quality standards and ensuring the continuous compliance of enterprises can the quality of Chinese drugs be effectively improved; if this opportunity is taken, 2015 will be used while further improving the scheme design of generic drug re evaluation The opportunity to upgrade the pharmacopoeia in, to upgrade the quality standards of some products in advance, and to eliminate the generic drugs that fail to meet the requirements, will certainly create a historic opportunity for the improvement of the quality of Chinese drugs " Chen Zhefeng pointed out It is reported that by 2020, all oral and injection type generic drugs in China will have to complete the quality consistency evaluation