Policy escort drug innovation

Innovation is the life of pharmaceutical industry and the only way to realize the dream of "pharmaceutical power" Under the premise of the formation of innovation consensus, the policy support for innovation is more clear, the industry is more active in the exploration of innovation, enterprises pay more attention to the value of innovation, and experts have more in-depth discussion on Innovation In this context, on July 27, the "new drug forum 2013 of the 48th national new drugs fair" (hereinafter referred to as new drug forum 2013) jointly sponsored by China Pharmaceutical News Agency, reed Pharma Exhibition Co., Ltd and China Pharmaceutical Industry Research Institute was successfully held in Suzhou as scheduled It is also the interaction between policy and market, as well as the communication between experts and enterprises It is also based on the national new special drug fair New drug forum 2013 inherits and carries forward the experience and advantages of new drug forum 2012, with the theme of "market, direction and trend", highlights the interpretation of new drug policy, focuses on hot spots in the field of research and development, discusses the implementation of innovation strategy, and focuses on model cases Analysis, by the pharmaceutical business related people's hot From 9:00 a.m to 4:00 p.m., the venue with about 160 people was always full Fang Xianye, President and editor in chief of China Pharmaceutical News Agency, and Hu kunping, general manager of reed Pharma Exhibition Co., Ltd delivered speeches respectively, wishing the forum a complete success The content of the forum in the morning is mainly policy interpretation, and the content of the forum in the afternoon is the introduction of experts to the current hot research and development categories, innovation of research and development mode and practical cases of enterprises (see the next draft for details) The organizer's awards to the top 20 innovative enterprises of Chinese pharmaceutical enterprises in 2013 have become the perfect end of the morning forum The new trend of drug registration development of the pharmaceutical industry is highly related to the policy direction The policy interpretation is still the core of this forum and the biggest concern of enterprises In his opening speech, president Fang Xianye pointed out that innovation is the inexhaustible driving force for the development of the pharmaceutical industry, the only way to realize the strategy of transforming from a pharmaceutical power to a pharmaceutical power, and the social responsibility and historical mission of the pharmaceutical people In pharmaceutical innovation, policies should be interpreted, experiences shared, and problems solved These are exactly what this forum looks forward to providing help and reference The role of relevant policies in guiding and encouraging drug innovation is self-evident Among them, strengthening drug registration management, improving the efficiency of new drug review and approval, encouraging the research and development of innovative drugs and generic drugs with clinical value will play a positive role in promoting drug innovation in China At this forum, the relevant person in charge of the drug and cosmetic registration department of the State Food and Drug Administration introduced the relevant situation and the latest progress of drug registration management He pointed out that from the current situation of drug Acceptance Review and approval, encouraging innovation has achieved initial results, but the situation of repeated R & D and application of generic drugs is still serious There are more than 20 drugs with approval numbers, and there are still 1272 anda applications in 2012 In terms of the efficiency of drug review and approval, the speed of review and approval has been improved to some extent, especially in the clinical trials of new drugs The approval of clinical trials of anti-tumor drugs only takes 6.1 months on average, but still can not meet the requirements of social and economic development Generally speaking, the current focus of drug registration management is to further improve the construction of registration related laws and regulations system, and vigorously improve the efficiency of drug review and approval, especially the efficiency of drug review and approval urgently needed in clinical At the same time, we should strengthen the management and supervision of APIs and pharmaceutical excipients to ensure the quality and safety of listed drugs In the next few years, the key tasks will mainly focus on the reform of drug review and approval mechanism, strengthening the supervision and management of drug clinical trials, improving drug standards, the consistency evaluation of generic drugs, and the research on macro policies and systems of drug management How to enter the medical insurance for new drugs is because most of the innovative drugs are expensive in the patent period If the medical insurance policy can give some support, it can not only greatly promote the satisfaction of clinical needs, effectively reduce the burden of patients, but also accelerate the industrialization process of new drugs In this regard, Qingdao social insurance bureau has made some meaningful explorations on the protection of high-value innovative drugs Liu junshuai, director of the social security department of Qingdao social insurance bureau, introduced their attempts at the forum Specifically, for innovative drugs with relatively expensive prices, the goal of "cost reduction" is achieved through the linkage of negotiation mechanism, CO payment mechanism and special supply mechanism; on the basis of reducing prices and costs, relief compensation is implemented to achieve the goal of "burden reduction" After one year's practice, Qingdao Medical Insurance has rescued 440 patients who need to use high-value innovative drugs The effect is outstanding All the patients who have been rescued survive The cost is 21.2 million yuan (less than 30% of the annual budget), and the per capita burden is 17000 yuan (less than 35% of the estimated value) Qingdao Social Security Bureau concluded that the establishment and improvement of high-value drug security system is not only a medical insurance problem, but also a comprehensive problem involving multiple departments The main problem is not money, but concept and management The formation of high-value drug security system means that the management mode of medical insurance drugs has been upgraded from extensive management to refined management, which means that the medical insurance drug service mode has been transformed from traditional medical service-oriented to patient-oriented.