原げん薬やく等など登とう録ろく原げん簿ぼ

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.

• 新しん薬やくの承しょう認にん申しん請せいには、原げん薬やく等など登とう録ろく原げん簿ぼの提てい出しゅつが必ひつ要ようです。

  Submission of a drug master file is required for new drug approval applications.

• 原げん薬やく等など登とう録ろく原げん簿ぼは、PMDAによって審しん査さされます。

  The drug master file is reviewed by the PMDA.