Drug safety management is an important issue in China drug management system and attracts great attentions from the whole society.In order to reduce drug incident,this study discusses some important elements associate...Drug safety management is an important issue in China drug management system and attracts great attentions from the whole society.In order to reduce drug incident,this study discusses some important elements associated with China drug safety management system and analyzes the data collected by questionnaires.Besides,a methodology for rating the important elements is described and applied.The non-structural fuzzy group decision method not only considers the insufficient precise information but also combines the opinions of different kinds of respondents in China’s four municipalities.The results indicate that the sample systems are the most important in these important elements,and the order of importance is sampling systems,licensing systems,traceability systems,transaction models,pharmacovigilance and emergence management.This study not only points out the important ranking of the pivotal elements in China drug safety management but also gives some specific proposals about how to enhance drug safety management in China.展开更多
This paper presented detailed information about the timeline of development of drug risk management in FDA. The time process was divided into three stages： the launch of laws and regulations of drug risk management, ...This paper presented detailed information about the timeline of development of drug risk management in FDA. The time process was divided into three stages： the launch of laws and regulations of drug risk management, pre-market approval and post-market safety supervision, adverse drug reaction and risk communication. To address the problems existing in drug risk management in China, suggestions to further and improve the development of drug risk management are proposed.展开更多
基金supported by a grant from Doctoral Foundation of Ministry of Education of China(Grant No.20070010014)the Program for a New Century of Excellent University Talents,Ministry of Education of China(Grant No.NCET-07-0056).
文摘Drug safety management is an important issue in China drug management system and attracts great attentions from the whole society.In order to reduce drug incident,this study discusses some important elements associated with China drug safety management system and analyzes the data collected by questionnaires.Besides,a methodology for rating the important elements is described and applied.The non-structural fuzzy group decision method not only considers the insufficient precise information but also combines the opinions of different kinds of respondents in China’s four municipalities.The results indicate that the sample systems are the most important in these important elements,and the order of importance is sampling systems,licensing systems,traceability systems,transaction models,pharmacovigilance and emergence management.This study not only points out the important ranking of the pivotal elements in China drug safety management but also gives some specific proposals about how to enhance drug safety management in China.
文摘This paper presented detailed information about the timeline of development of drug risk management in FDA. The time process was divided into three stages： the launch of laws and regulations of drug risk management, pre-market approval and post-market safety supervision, adverse drug reaction and risk communication. To address the problems existing in drug risk management in China, suggestions to further and improve the development of drug risk management are proposed.
