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1引言一直以来,药物安全问题都受到患者及处方医生的密切关注。近来,药品安全问题更是频上媒体头条。焦点问题则包括上市后药品新发现的不良反应,药品生产过程中可能出现的“造假”现象等。公众对药品安全的关注最早可追朔到1848年,美国国会通过了药物进口法案,要求美国海关官员停止从海外进口不安全药物或者假药[1]。从那时起,全世界大部分国家相继立法,对进口药品及本国生产的药品进行管理。
1 Introduction All the time, drug safety issues are closely watched by patients and prescribers. Recently, the problem of drug safety is frequently the headline of the media. Focus issues include the newly discovered adverse drug reactions after the listing, pharmaceutical production process may occur “fraud ” phenomenon. Public concern about drug safety dates back to 1848, and the U.S. Congress passed a Drug Import Act that requires U.S. customs officials to stop importing unsafe drugs or counterfeit drugs from overseas. Since then, most countries in the world have successively legislated to regulate the importation of drugs and their own manufactured drugs.