Drug master files (DMFs) are an essential element of the chemistry, manufacturing and controls (CMC) section of the drug and biologic application submission process in the United States and Canada.
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- 药物主文件(系数)的重要组成部分；化学；制造和控制(管委会)组药物和生物学提交申请的过程中；美国和加拿大.；Both the FDA and Health Canada hae DMF systems
