More than 80% of China's generic drug industry has repeated application or is facing reshuffle

2013-04-26 source: 39 in 2012, there were 2095 newly declared generic applications by HealthNet, and the number of drugs with more than 15 approval numbers accounted for 81.3% of all generic applications in 2012 Li Mei, Professor of the Institute of pharmaceutical biotechnology, Chinese Academy of Medical Sciences, surprised the audience at the conference on conformity assessment and GMP certification of generic drugs Most of the 180000 drugs on the market in China are generic drugs These generic drugs play an important role in meeting people's medical and health care needs, but there is still a certain gap between the quality and the international advanced level as a whole, and there are also large quality differences between the generic drugs of the same category In the application period of generic drugs from 2002 to 2006 in China, the technical requirements for dissolution are almost blank, only the dissolution test specified in the existing quality standards is required, which results in the poor clinical efficacy of some domestic solid preparations (especially insoluble drugs and sustained-release preparations) compared with the imported original products The State Food and Drug Administration issued the work plan for quality consistency evaluation of generic drugs, comprehensively launching the consistency evaluation of generic drugs approved before October 1, 2007 Li Mei said that the new regulations issued by the State Food and Drug Administration regulated the selection principle of generic drugs, increased the inspection of the production site before approval, provided the application materials according to the requirements of the production application, emphasized the comparative study, and strengthened the process validation At the same time, the State Food and Drug Administration issued a series of technical guidelines, gradually improved the system construction of generic registration laws and regulations, established the framework of generic research technical specifications, introduced internationally accepted technical requirements and standards, and initially put forward the concept of quality control combining process control and key control Due to the imbalance of drug R & D level and evaluation standard mix, different countries may have very different conditions for approving drug listing For drugs developed in the early years, there may not be enough supporting data to be approved for production and marketing In 2012, the State Food and drug administration adjusted the review and approval strategy On the one hand, it established priority review areas and focused on the review and approval power On the other hand, it guided enterprises to apply rationally through the evaluation of listing value and pharmacoeconomics The industry believes that China's pharmaceutical industry has not turned around for many years, "how small and disorderly", overcapacity, disordered competition stubborn disease stems from two time periods In fact, according to the market rules and experience, it's easier to make profits if there are 10 pharmaceutical manufacturers If there are 30 pharmaceutical manufacturers, it's hard to make profits When there are 50 or even 100 pharmaceutical manufacturers, the market will be ruined, leading to disordered competition and even quality risk With the development of China's economy and the improvement of people's living standards, improving the manufacturing level and quality of generic drugs, reducing the cost of diagnosis and treatment by improving the curative effect, and achieving the "divine resemblance" with the generic drugs are the needs of social development, as well as the way out and direction for the pharmaceutical industry to give full play to its production capacity advantages and then enter the international market