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Research On The Drug Recall System In China

Posted on:2012-01-12Degree:MasterType:Thesis
Country:ChinaCandidate:X C XuanFull Text:PDF
GTID:2219330368995054Subject:Public Management
Abstract/Summary:PDF Full Text Request
Drug is a kind of special commodity, it is very important for people's health, We must regulate its quality, safety and efficacy. In order to protect consumer's rights, our country pays more and more attentions to the legislation of defective product recall system. After several years development, especially after reform and opening, the drug administration of AnHui province has been built up. Chinese State Food and Drug Administration also adopted the "Administrative Measures for Drug Recalls" on December 10,2007, marking China's drug recall system was formally established.These have taken effect in the regulation of drug making and recall. But with the stride of reform and opening and development of market economy, the problems of current drug recall administration system have emerged. For example, China's drug recall system is still lack of higher-level laws; and lack of an effective evaluation system for the recall signal, etc. It influent the safe and stability of drug, also has hindered the development of drug enterprise, and eventually will influence the healthy of people.To strengthen the implementation of Drug Recall Administration, this dissertation explores the building of new drug administration system based on the analysis of the current drug recall status both in China and abroad, effective measures for the enforcement of the regulation was presented. And expounds the necessity of the legislation of defective product recall system.The conclusion of this desertion is that we must reform current drug recall system to meet the need of market economy; in the initial enforcement stage of Drug Recall Administration, some relative effective measures should be taken from the aspects of drug manufacturing enterprises, consumers and the related supporting regulations to ensure the effective enforcement of the defective drug recall.This thesis is composed of 6 chapter, about 3,0170 words,56 references.
Keywords/Search Tags:drug recall, pharmacovigilance, defect product, adverse drug reaction
PDF Full Text Request
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