noun
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.
新薬の承認申請には、原薬等登録原簿の提出が必要です。
Submission of a drug master file is required for new drug approval applications.
原薬等登録原簿は、PMDAによって審査されます。
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.