62 generic drugs selected by the drug examination center are all the varieties whose foreign patents are about to expire

Source: wisdom 2014-5-16 an official from the National Drug Review Center (CDE) told reporters that this year, the center will actively cooperate with the General Administration of China to promote the construction of the priority evaluation system for generic drugs in clinical needs Currently, 62 "The list of varieties has been determined, discussed and implemented internally, and the review will be accelerated together with innovative drugs." The official said that the common feature of the 62 varieties is that the original research patent is about to expire in 2014, there is no domestic drug listed in China, and the enterprise has applied for the varieties to the drug evaluation center "For the varieties whose patents are about to expire, only some of them are imported from China, but no domestic products are available Such varieties are urgently needed in clinical practice, with good safety and effectiveness, and the State Administration is considering accelerating the overall review." According to statistics, from 2013 to 2014, there are 89 varieties of original research drug patents about to expire It is a topic widely criticized by the pharmaceutical industry that the number of drug reviewers is too small and the task of drug review is too much, which leads to the slow speed of drug review At the same time, the number of generic drug applications is increasing, which wastes limited review resources It is understood that from January to April this year alone, more than 2000 generic drugs have been declared to CDE by domestic and foreign enterprises According to the officials, the limited review resources should be shifted to generic drugs with high clinical treatment value and clinical urgent need to solve the problems of public access and affordability.