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Drug Safety Regulation In China Problems Countermeasures

Posted on:2013-07-17Degree:MasterType:Thesis
Country:ChinaCandidate:W W HanFull Text:PDF
GTID:2246330395458966Subject:Law
Abstract/Summary:PDF Full Text Request
Food can solve the adequate food and clothing, Drugs was able to drive away thedisease, bringing health. Drugs as a special commodity, drug safety is not only relatedto the health of the masses of the people, but also related to the development andstability of the state and society. Drug safety problems become major issues; ability toenhance trust between people, between enterprises, standardize the economic order,truly harmonious society, but also to become the relationship future generations to thesustainable development of major problems. With the rapid development of China’seconomy, the growing size of the pharmaceutical industry, a number of major drugsafety incidents from time to time have occurred to cause significant loss of life andproperty of the masses. Since1998system reform, China’s drug safety regulatorshave basically established the unified leadership of the central government, provincialdrug supervision and management of the following vertical management system, to acertain extent on the optimization of the administrative allocation of resources, andimprove the efficiency of supervision. China’s drug safety issues, however, has notbeen effectively resolved, especially in recent years, with the rapid development ofthe pharmaceutical industry, drug safety accidents occur frequently, pieces of theshocking drug safety accidents have touched public fragile nerves, the attention fromartificially high drug prices, medical treatment is difficult and expensive, up attractedto drug safety issues. Institutional restructuring of the State Council of the Food andDrug Administration in2008to return to the management of the Ministry of Health,ten years of pharmaceutical management system change, a reflection of thedifficulties of drug supervision and management system to build. As the firstresponsibility of drug safety and quality, fake or substandard drugs productionenterprises to blame, but the regulatory agencies as approved fake medicinessubstandard drugs into the market is difficult to shirk its responsibility. Enterprise noshortage of drug safety incidents through the pharmaceutical production and qualitymanagement norms "(GMP), the the drug regulatory senior staff have been sacked,and all exposed the vulnerability of China’s drug regulatory. The emergence of drug safety accidents not only the public loss of confidence in the pharmaceutical market,leaving the public to doubt our government administrative capacity.To strengthen, improve drug safety supervision system, follow questions, analyzeproblems, the general argumentation method to solve the problem, analyze the currentdrug safety supervision system, the perfect combination of advanced foreignexperience and practice on the basis of strengthening China’s drug safety monitoringsystem is put forward specific proposals.This paper studies the content is divided into four chapters. Chapterinterpretation of China’s drug safety supervision system overview. Understanding ofChina’s drug safety regulatory development, characteristics and status quo fromwhich to explore the problems exposed by China’s drug safety supervision system, tohighlight the problem of universals, to prepare the ground for the second chapter.Second chapter of China’s drug safety regulatory problems exposed DiscriminationCause Analysis to lay the foundation for the analysis of problems of China’s drugsafety supervision, Discrimination problems include serious drug safety and frequentaccidents; the poor new drugs listed cause corruption cases; medicine industrialdevelopment of the situation is worrying; serious problems in four areas of the fieldof drug use. Chapters III and IV are the focus of this article. Chapter from the lawsand regulations of China’s drug safety supervision is not perfect, the drug regulatorystandards fuzzy, chaotic drug regulatory agencies, the drug regulatory body is weak,and the main players in the market is missing the five aspects of the problem of thedrug safety supervision and detailed analysis, check due Reserved fruit. The fourthpart of the "right" way, combined with advanced foreign experience and practice, andto propose specific measures to strengthen to improve drug safety supervision inChina. Part for the third part of a reason to put forward measures to address China’sdrug safety supervision, to that perfect drugs, drug safety, regulatory laws andregulations; to increase pharmaceutical market, the main regulatory efforts;continuously enrich the main force of drug safety supervision; to strengthen externalsupport forces building and to accelerate pharmaceutical economic development,enhance the awareness of corporate self-regulation in these five areas, to effectivelyrespond to the problem of China’s drug safety supervision system to ensure the safety of the people and medication, and to promote the healthy development of China’sdrug safety supervision.
Keywords/Search Tags:Drugs, Drug Safety, Regulatory Regime
PDF Full Text Request
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