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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- 藥物主文件(系數)的重要組成部分；化學(xué)；制造和控制(管委會(huì ))組藥物和生物學(xué)提交申請的過(guò)程中；美國和加拿大.；Both the FDA and Health Canada hae DMF systems
