Research On Innovation Vitality Of Pharmaceutical Enterprises Under The Background Of Drug Registration System Reform

The pharmaceutical industry is a special industry which focusing on prevention, diagnosis and treatment of disease, rehabilitation care and enhancing the quality of the national health. Drug is closely related with health and there is individual difference in use, so it requires dynamic regulation. New drugs always need more attentions among all kinds of medical products. With the improvement of living standards, the demand for medical treatment is becoming higher and higher. For individuals, the existence of drugs is directly related to whether the patient can be treated timely and effectively. The supply of innovative drugs affects the health of human society and the delivery of social civilization. For enterprises, R&D capability is the core competitiveness of pharmaceutical enterprises. The new drug is the external performance of the core competitiveness of pharmaceutical enterprises. The fundamental purpose of the pharmaceutical business is to introduce the medical products approved by the doctors and patients, and to obtain benefits. Investment- innovative products- Revenue-reinvestment- new innovative products, which is the sustainable development cycle for pharmaceutical enterprises. It is the only way for successful pharmaceutical companies that continue to enhance the R&D capabilities for new drugs and introduce of innovative products with significant clinical advantages in the medical market. New drug discovery is so important for human health while research and development of new drug is a high-tech, high investment, high return, high risk and long cycle of investment behavior that it should be the responsibility of both the business and the government. The ability of new drug research and development is not only related to the development of pharmaceutical companies, management experience, but also related to medical incentive policy, the great mechanism for venture capital investments, the extent of payments for national health insurance and other factors. Therefore, government and enterprises play a very important role in the process of new drug research and development together.Drug registration system refers to the administration from CFDA in accordance with legal procedures for approval of drugs which can be admitted that the registered drug safety, effectiveness, quality control after systemic evaluation. Drug registration system relates to R&D and production, it plays a policy-oriented role in the creation of new drugs and influences the chain of distribution and marketing. Since the founding of the government, China steadily push forward the reform of pharmacy Drug registration system. At this stage, the core of drug registration system is to solve the problem of drug accessibility, to promote the development of the pharmaceutical industry with the help of the policy. In the early days of the founding of the PRC, it was weak for the foundation of pharmaceutical industry and basically relied on imported drugs. Under the planned economic system, the state promotes the growth and development of the pharmaceutical industry through policy deregulation. However, everything has two sides, the broad definition of new drug, strict clinical trial approval standards, the lower the generic evaluation standards, these policies create space and profit for development of pharmaceutical enterprises,at the same time, reaction inhibited the enthusiasm of innovation of pharmaceutical enterprises. Pharmaceutical companies used to the generic drug price competition and ―gold sales‖ profits, put few part of resources into the research and development of new drugs. Drug R&D levels remain in the copy and the track target based on the foreign innovation. The ability of pharmaceutical enterprises drug research and the production innovation is limited, enterprise development ultimately subject to the abnormal order of market competition. The broad definition of new drugs and generic drugs, the ambiguous boundaries, lead to serious phenomenon of duplication of drugs, coupled with the limited human resources in National Center for drug evaluation, resulting in serious problem of drug review backlog.In August 2015, China Food and Drug Administration issued document "View on the reform of Drugs and Medical Devices approval system" and a series of guidance documents as followed in order to solve the problems appeared in the process of drug registration system. It suggested that the new round reform of drug registration system had already begun. It is expected to be approved by Government that these policies can guide and correct the development of pharmaceutical enterprises, solve the backlog of drug registration review, regulate the behavior of pharmaceutical research and development and encourage the creation of new drugs. These policies conclude improving drug registration approval standards, improving the clinical trial approval standards carrying out the pilot work on Marketing Authorization Holder and etc.The purpose of this reform is to explore how to stimulate innovation vitality of pharmaceutical enterprises under the background of the new round reform of drug registration system. The study explored the necessity, ideas and measures of the reform and compared R&D mode between China and foreign country., It is also put forward to the solutions for the difficulties which the enterprises encounter in management and improving the innovation vitality of pharmaceutical enterprise.At first, the quantitative analysis is used to expound the necessity of the reform by using the monitor data of China State Pharmaceutical Industry Information Center in this study. Secondly, investigation is carried out for the pharmaceutical enterprises in a certain city called ―A‖, a southern province as a representative of many small and medium-sized pharmaceutical enterprises and it is summarized about the current situation of drug discovery of Chinese pharmaceutical enterprises. Thirdly, it is introduced some measures of the reform and analysis of the prospect of drug discovery of pharmaceutical enterprises through longitudinal comparison method. Fourthly, it is main context to study the patterns of drug discovery between China and foreign countries using the transverse comparison method. Then, the antitumor drugs in the precise medical treatment is taken for an example to study the difficulty of the high clinical value drug faced in China from the aspects of cutting-edge technology, product structure, sales and market access. Finally, the study provides strategies for the development of pharmaceutical enterprises to inspire creativity of new drugs under the background of the deeper reform of drug registration system.The innovation of this research is to study the plight of private small and medium-sized pharmaceutical enterprises faced in the new drug research and development and business process, while carried out a survey for an area of the pharmaceutical industry as selected and combined, and put forward the development suggestion combined with the current reform trend. The deficiency of this research is that it is not involved about research on large enterprises and a wider range of enterprises, more in-depth analysis of the data model, which can be worth further studied.