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Challenges in the process of new drug application

Views:0     Author:Site Editor     Publish Time: 2016-01-28      Origin:Site

        Many new drugs chronic adverse reaction after the listing only gradually revealed, the clinical data of need in clinical use after the listing, or after the listing of clinical trials, so directly relates to the phase IV clinical trials.
        By the above know, the process is the application of the application by the applicant stage, involving the monitoring of drug market. September 30, 2004, the Merck Co's osteoarthritis litigation cases, the Merck Co to face about tens of billions of litigation costs. According to a memo from the U.S. Food and drug administration, the drug caused 28000 people to have heart attacks and deaths during the period from 1999 to 2003. Merck Co's own clinical trials report also showed 18 months of continuous use of carvedilol, heart attack rate of the control group of high.
        In this case, the United States Food and drug administration is also in an embarrassing position, has been criticized by many. 3.4.1 the lack of compensation mechanism in our country, because the medical compensation system is in the initial stage, a lot of medical tort caused by medical damage compensation mechanism is in the lack of state. In clinical trials, for the unknown, high risk factor of the industry is involved, in the test process, such as trying to hurt, can't find corresponding medical compensation, personal insurance and economic compensation mechanism.
        3.4.2 contract research organization professional level is not high with the continuous development and improvement of the relevant laws and regulations on drug clinical trials, the research and development of new drugs become more complex and lengthy, the cost is higher. As long as the enterprise management is strict, the competitive environment in order to survive and develop, it is necessary to shorten the time for new drug research and development, control costs and reduce risk. Is also the breeding ground for the contract research organization, the prominent function is to develop clinical trial program and drawing up test plan and develop cooperation contract, the design content of the importance for the clinical trials link is an indispensable part of. At the same time, such an organization, the level of work and management coordination ability is directly related to the quality and efficiency of drug clinical trials. But in China's CRO is still in its infancy, for its own business scope and business model is not clear, lack of practical experience, work efficiency is not high, the lack of international professionals.
        With the development of medical science and the continuous improvement of relevant laws and regulations of our country, the development of CRO itself has been caught in the bottleneck, which makes it have to take measures to improve their professional level.




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