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一、药品质量标准的分类《药品管理法》第二十三条规定,药品必须符合国家药品标准或者省、自治区、直辖市药品标准。国家药品标准又分《药典》及《部颁药品标准》,连同各省、市、自治区的地方药品标准简称为“三级标准”。 1.中国药典:由卫生部药典委员会编纂出版,经国务院同意由卫生部颁布执行。国家药典应能反应出我国的医疗预防、医药工业和
First, the classification of drug quality standards Article 23 of the Drug Administration Law stipulates that drugs must meet the national drug standards or drug standards of provinces, autonomous regions and municipalities directly under the Central Government. National drug standards are divided into “Pharmacopoeia” and “ministerial drug standards”, together with the provinces, municipalities and autonomous regions, local drug standards referred to as “three standards.” 1. Chinese Pharmacopoeia: compiled by the Pharmacopoeia Commission of the Ministry of Health Publishing House, approved by the State Council promulgated by the Ministry of Health. National Pharmacopoeia should be able to reflect our country’s medical prevention, pharmaceutical industry and