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
**FDA Drug Master Files**
The FDA Drug Master File (DMF) system is a repository of manufacturing information on human drug substances, drug products, and drug delivery devices submitted to the FDA by drug manufacturers.
The DMF system allows manufacturers to submit detailed information about their manufacturing processes, which can be referenced in drug applications to support the safety and quality of the drug product.
This system helps to streamline the drug review process and reduce the need for duplicative submissions of the same information.