OTC药评审的法律依据和程序
The legislation and legal procedures of Rx to OTC switche
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摘要: 处方药和非处方药(Rx&OTC)分类管理制度是由国家法律强制推行的药品管理制度。药品、制剂或活性成分的OTC身分也是根据有关法规、履行法定的审批程序而确立的。我国正在酝酿的Rx&OTC分类管理制度对公众甚至药学从业人员都是陌生的新事物,有必要通过介绍国外现行该制度国家的做法,了解有关OTC药的立法以及药品确立OTC身分的合法程序,作为我国即将出台的Rx&OTC分类管理制度的借鉴。Abstract: The paper briefly reviews the statutory definition of prescription drug (Rx) and non-prescription drug (OTC),the statute and regulations of Rx&OTC classification system,and the criteria employed in determining whether a drug is marketed by prescription or OTC in the other countries.We then outline the legal procedures of Rx to OTC switches in the United States.
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Key words:
- Prescription drug /
- non-prescription drug /
- OTC switche /
- regulation of OTC
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