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The Application Research of Pharmacoeconomics in Drug Registration of China

Author: RenZhenLi
Tutor: WangZiShou
School: Chengdu University of Traditional Chinese Medicine
Course: Of Pharmacy
Keywords: Pharmacoeconomics Drug Registration Review and application Management model
CLC: F426.72
Type: Master's thesis
Year: 2010
Downloads: 190
Quote: 0
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Abstract


Objective: To explore the pharmacoeconomics of drug registration applications necessity, feasibility and application of innovative drugs, generic drugs and change the dosage form drug registration method to build a management model of Pharmacoeconomics in Drug Registration in China. Methods: The literature collection broad understanding of the drug economics theory, evaluation methods, and its domestic and international development and application of the status quo. Through field research in Sichuan Province Food and Drug Administration Drug Registration Department, Drug Safety Supervision Department and part of pharmaceutical research, production and enterprises to understand the drug registration in China's relevant laws and regulations, the requirements for disclosure of information, management procedures, and reporting of drug registration to run for Registration of Pharmaceuticals The enterprise content analysis of the problem of drug registration in China and explore solutions countermeasures. Interview for Drug Evaluation Specialist and tracking of the State Food and Drug Administration Center for Drug Evaluation website, to understand our form of the drug registration review, contents, methods and evaluation institutions set content. Finally, the comprehensive comparative analysis of pharmacoeconomics differences exist in the application at home and abroad, looking for useful experience. Results: The above content analysis and research, from the optimized configuration medicine resources, enhance the anti-risk ability to play to guide the functions of the government and effectively solve the problems left over by history on four aspects of drug economics of drug registration necessary sex. Drawn from the four aspects of the basis of our existing technology base, the institutional base, staff, foundation and policy feasibility of the application of pharmacoeconomics in drug registration in China. By analysis of the relationship between Pharmacoeconomic evaluation of other drug registration review content, derived directly or indirectly affect the drug's safety, effectiveness and quality control drug economy, drugs economic theory can be used to explain Pharmacoeconomic evaluation of the content in the registration of drugs, generic drugs and change the formulation varieties. The final set from the guiding principles, institutions, technology system, personnel training and drug registration in China run program to build the application management model of pharmacoeconomics in drug registration in China. Conclusion: theory and scientific applications of pharmacoeconomics in drug registration in China is conducive to improve the overall level of R \u0026 D and registration of drugs listed success rate for the approval of drugs, at the same time, the rational use of health resources and conservation. Pharmacoeconomics introduction of our time is shorter, existing talent and technology base is relatively weak so smoothly carry out their practical application of drug registration in China, the government and the competent departments should attach great importance to, \The Registration \

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CLC: > Economic > Industrial economy > China Industrial Economy > Industrial sector economy
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