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Sfda and fda 8 years and 100 years-sfda fda-pharmaceutical industry - master switch by erhtt esrhtrfn





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Sfda and fda 8 years and 100 years-sfda fda-pharmaceutical industry - master switch by
Article Posted: 05/17/2011
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Sfda and fda 8 years and 100 years-sfda fda-pharmaceutical industry - master switch


 
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100th anniversary of the establishment. China in 1998 set up an independent regulatory agency specialized drugs?? State Drug Administration has also 8 years. State Drug Administration in 2003 officially changed its name to the State Food and Drug Administration (SFDA). FDA Food and Drug Administration on the successful model has become the light of the experience of relevant government agencies. Here, we would like to take U.S. drug administration compared with drug administration in an academic study to make.

Experts Chinese representative: Shao Rong?? China Pharmaceutical University International Business School Dean of Medicine and Law, Policy and Law for many years in Pharmacy Administration Teaching and Scientific Research.

U.S. Representative: Chen Shaoyu?? Graduated from Beijing University, the only known within the industry to understand bilingual and fluent in the United States Food and Drug Law lawyers. During the period from 2000 to 2004 and practiced law in the FDA. Currently working in the Seattle law firm Davis.

FDA after years of development, today in the United States and the institutions of world government is quite extensive. You think the FDA is most worthy of national government agencies learn from experience like what?

Chinese representative (the Chinese): FDA has the following points should be national reference.

First, FDA attaches great importance to science. This not only reflected in the FDA on the importance of science technology, such as there must be sufficient evidence to prove safe and effective drugs to allow the public, as far as possible the most advanced testing instruments and equipment used in food, drug testing. In addition, FDA in monitoring the measures, the method also attach importance to science, such as China has implemented GLP, GCP, GMP and so proved to be very scientific. In the promulgation of a set of revised regulations Shihai scientific procedures to ensure that the promulgation of revised rules of operation.

Second, FDA focus on improving the relationship with the consumer. FDA to consumers in their own time stressed that he is protecting the American public health organizations, consumer protection, rather than highlighting that they are federal law enforcement agencies. To do this, FDA has many links of contact with consumers, such as the FDA to develop, the revised regulations, no person has the right to comment, to ensure the full participation of the public. FDA also has year-round contact with the consumer to receive complaints or reports related issues.

Furthermore, FDA is valued and good cooperation. Although the FDA and other federal government agencies with the U.S. division of a clear, distinct responsibilities, but still needs supervision in many areas of full cooperation with other departments. If the special drug control with the United States DEA (Drug Control Administration), in the advertising of non-prescription drugs with the FTC (Federal Trade Commission) in cooperation with the Ministry of Agriculture in food products and so on. Full collaboration with relevant departments, cooperation to ensure the FDA regulated products comply with legal requirements, but also improve administrative efficiency.

The United States on behalf of (the U.S.): respect for science, this is what I wish to emphasize. With solid FDA safety and efficacy of the relevant evidence to approve an application for registration of new products. They do not value non-scientific information, such as certificates, rumors, and other observations failed.

China's drug administration and system for building a large extent with reference to FDA's experience, but a hundred years in the history of FDA review found that many U.S. Food and Drug Administration in the history of some of the problems have occurred, and now still in China reproduce, which is similar to FDA because the system itself, there are still some lack of it?

China: China's food and drug monitoring body in the establishment and institution building on the many aspects of the experience of actually drawing the FDA. In general, this choice is correct, you can avoid detours to ensure that the product meets the relevant legal requirements and supervision. In recent years, China's food and drug regulatory achievements are obvious to all. For why many in the U.S. Food and Drug Administration history of some of the problems have occurred, and now still in China to reproduce, such as the recent "Let the two drugs" production "Armillarisin injection" using counterfeit accessories, I think : First, the United States derived from practice and supervisory experience is certainly valuable, but will first need to learn regardless of their profound meaning and essence, not just formal reference; Second, differences in conditions between the two countries is large, the American experience must be integrated with China's national conditions and to fully play a role; Third, although the emergence of the problem is regrettable, but it should be noted that in such a short time, identify problems, find out the reason, timely response, the implementation of prevention measure itself in these years our country has made great achievements in the drug administration the best example; Moreover, national food and drug supervision and are constantly improving, the level of its regulation are found to solve problems during the process of ever-increasing.

U.S.: Law is always room for continuous improvement, whether in the United States or China. For example, in evaluating the safety and efficacy when the risks and benefits is always a need to balance the contradiction. The United States today, there occasionally listed after a drug proven dangerous, and then face delisting and the compensation deal with the phenomenon. Therefore, in order to prevent similar problems, the law requires the further development and improvement, this development needs the legislators and experts to compile a better law, but also need to give law enforcement a better expression.

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