hot
Login
FDA原辅包登记*DMF

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。

Visit

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 human drugs. This submission is used to support an application for marketing approval of a human drug product.