Study On Risk Management Of New Drug R & D In Pharmaceutical Enterprise

The pharmaceutical industry is related to the people's health and life safety, since reform and open up it is the fastest developing potential development of high technology, high yield, high risk of industry. New drug development prop up the development of the pharmaceutical industry, only in the way that the constantly new drug development can make pharmaceutical industry invincible in the market competition,at present the international medicine market share was monopolized by several famous transnational corporations, Because they are relying on first-class talents and technology , strong economic strength and high investment, put the good quality new drug continuously in to market ,this both bring benefit to human, but it also bring huge economic benefits to the firm.But the great profits often accompanied with huge risks, new drug R&D has the features of great input, long life cycle, high-tech, and it is a complicated system process that based on the multitudinous scientific theory and the latest technology,and require a series of steps such as the design of compounds,synthesis and compounds, efficacy and safety evaluation and selection, clinical evaluation and quality inspection. Currently the approal average of developed countries develop a new drug need 200 billion , some even $1 billion dollars, the direct research costs of domestic innovation drugs to the market also needs tens of millions of dollars and the average variety needs twelve years, therefore,new research on effective risk management is particularly important.Drug risk management is mainly by means of quantitative risk identification, risk assessment, such activities for new drug R&D process analysis of the risks involved in planning, control and supervision. Thus increase the opportunities of corresponding risk and improve the success rate of drug research. Research shows that at present the new medicine risk management theory and research method is not perfect, this mainly embodies in risk identification, risk evaluation and quantization error of the risk analysis tool selection, etc.This paper is based on the new drug R&D of enterprises as the research object,starting from the basic theory of risk management, put forward the basic procedure and methods of risk of drug research. combining with new drug R&D situation of pharmaceutical enterprise. According to train of thought of the risk identification -- risk assessment of risk -- risk management . Finally we proposed some proposal to help to strength the medical enterprise of drug research, and strived for the systematic analysis and summary of the risk management,furtherly to strengthen the pharmaceutical enterprise, so as to provides useful reference for the risk management of drug research drug research risk for our country pharmaceutical enterprise.