英语翻译Full Drug Master File is not required for Silver,because

来源：学生作业帮编辑：神马作文网作业帮分类：英语作业时间：2024/11/11 10:39:08

英语翻译
Full Drug Master File is not required for Silver,because this is inorganic substance.But maximum information about manufacturing,purity,action,and clinical use of Silver.Also some Certificates for good manufacturing practice for medical active substance for manufacturer of silver (medical substance) or if there was any European inspection,add report from this inspection.

由于银是无机物,所以无需提交全套药物主文件.但应就银的制造、提纯、作用以及临床应用提供尽可能多的信息.同时需要提交能证明银制造商在制造医用活性成分时业绩良好的证书,如果需要欧洲的检测,还需要附加这一检测的报告.
备注：Drug Master File(DMF)---药物主文件.这是制药厂提交给药品管理机关的文件,其中包括药物生产设施、生产工艺或制造、生产、包装以及存储所用到的材料等机密详细信息.
欧洲名称：
European Drug Master File (EDMF)---欧洲药物主文件
Active Substance Master File (ASMF)---活性成分主文件
美国名称：
US-Drug Master file (US-DMF)---美国药物主文件

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