我国《药品管理法》与美国相关法规中关于假劣药界定的比较分析及启示

目的：全面理解假劣药的界定，为完善药品管理法规提供参考。方法：将现行2001年版《药品管理法》与1984年版《药品管理法》和美国1983年《联邦食品、药品和化妆品法案》（FDCA）中关于假劣药的界定进行了分析比较，并提出相关的建议。结果与结论：现行版《药品管理法》与1984年版《药品管理法》相比，其中关于假药的界定取消了“与省、自治区、直辖市药品标准规定不符合的”情况，取消了地方标准；按假药论处的情形新增加了2条。FDCA和现行版《药品管理法》对假劣药品的规定有着本质的区别，FDCA将药品划分为违标药品和伪劣药的分类标准既明确又科学，我国对假劣药品的划分标准借鉴了FDCA的划分方法。但现行版《药品管理法》还存在将劣药的一种情形作为劣药的界定，犯了内涵过大、外延过小的错误。建议有必要增加新的款项来有效打击假劣药品，同时还应当增加包括无需检验即可判断和确定的劣药具有相同或相似危害性的所有药品的相关内容。

Comparative Analysis of Drug Management Law in China with Related Laws and Regulations in America about the Definition of Counterfeit and Inferior Drugs and Its Enlightenment

OBJECTIVE： To fully understand the definition of counterfeit drugs, and to provide reference for the improvement of laws and regulations about drug management. METHODS ： The definition of counterfeit drugs and inferior drugs in present Drug Management Law （2001 edition） was analyzed comparatively, compared with Drug Management Law （1984 edition） and U.S. Fed- eral Food, Drug and Cosmetic Act （FDCA） in 1983. Related suggestions were put forward. RESULTS ＆ CONCLUSIONS： Com- pared with Drug Management Law （ 1984 edition）, the definition of counterfeit drugs, ＂which are not in line with drug standards is- sued by province, autonomous region and municipality city＂, and local standard have been cancelled in present Drug Management Law; 2 provisions are added about the definition of inferior drugs. There are essential differences of the definition of counterfeit drugs and inferior drugs between FDCA and present Drug Management Law. The classification criteria of misbranded drugs, coun- terfeit drugs and inferior drugs in FDCA are accurate and scientific, and they are used for classification criteria reference of counter- feit drugs and inferior drugs in China. However, that one condition of inferior drugs regarded as the definition of them in present Drug Management Law, results in excessive connotation and undersize extension. It is suggested that new items are necessary to crack down on counterfeit drugs and inferior drugs effectively; the items are required about inferior drugs which can be judged and defined without test show same or similar perniciousness.