drug master file; DMF
A regulatory document filed with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) containing detailed information about the manufacturing, processing, and quality control of active pharmaceutical ingredients and other drug substances.
Submission of a drug master file is required for new drug approval applications.
The drug master file is reviewed by the PMDA.
A compound of 原薬 (げんやく, 'active pharmaceutical ingredient'), 等 (など, 'etc.'), 登録 (とうろく, 'registration'), and 原簿 (げんぼ, 'ledger' or 'register'). The term is a direct translation of the English 'drug master file' used in pharmaceutical regulation.