FDA原辅包登记*DMF
Site information
药物主文件，即Drug Master File (DMF)，是呈交FDA的存档待审资料，资料内容包括有关在制造、加工、包装、储存、批发人用药品活动中所使用的生产设施、工艺流程、质量控制及其所用原料、包装材料等详细信息。
Highlights
The Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The FDA uses this information to evaluate the safety of human drugs.