《中华人民共和国药品管理法》规定,药品必须符合国家药品标准或省、自治区、直辖市药品标准。从执法的角度讲,药品标准是评定药品质量的法定依据。而药典则是有关药品质量标准的最高法规。它是由国 “People’s Republic of China Drug Administration Law” provides that drugs must meet the national drug standards or provinces, autonomous regions and municipalities drug standards. From the perspective of law enforcement, drug standards are the legal basis for the assessment of drug quality. Pharmacopoeia, on the other hand, is the highest statutory regulation on pharmaceutical quality standards. It is made by the country