| Despite that CFDA(China Food and Drug Administration) issued the “the provisions on the administration of the pharmaceutical instructions and labels” in 2006 intending to regulate pharmaceutical instructions and labels of all listed drugs, quite a number of irregularities still remain in pharmaceutical market, which cause great harm to patients. Two cases in point are Carbamazepine case and Wenjiang Fuling pill case which show that the pharmaceutical instructions lead to many controversies in terms of tort liabilities. Given that the warning defect resulting from inadequate pharmaceutical instructions has been increasingly attracting attention of drug manufacturer, it is urgent to regulate the pharmaceutical instructions.The present study aims to explore mechanism of irregularities of warnings by means of analyzing linguistic features of irregularities of the warning of Chinese pharmaceutical instructions based on empirical research of comprehension evaluation, revealing the standpoint, attitude and ideologies behind words in order to explore reasons for irregularities of pharmaceutical warnings and proposing some guidelines to regulate the specifications of the warnings of Chinese pharmaceutical instructions.Combining quantitative and empirical analysis together, the thesis conducts a tentative analysis on 119 pharmaceutical warnings based on survey of comprehension evaluation and questionnaire to explore the irregularities of pharmaceutical warnings. It is found that the irregularities of pharmaceutical warnings can be divided into five categories: incomplete statement, too technical wording, non-prominence, inexplicitness and false information. The thesis proposes systematic guidelines of regulating pharmaceutical warnings on the basis of empirical research. Hopefully, the present study may shed light on designing warnings for pharmaceutical manufacturers and enrich the research of warnings. |
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