DMF 各国別　eCTD/eSubmissionの実際（作成・登録・更新・変更・LOA）【第12回】

DMF制度は医薬品の承認・許可申請において、製造業者が原薬・原材料に関する製造や品質に関する情報・知見・ノウハウをDMFとして規制当局へ直接登録しておくことで製造販売業に開示しなくても承認・許可審査が実施される制度です。MFは原薬の承認申請書に代わる文書としてまたは原材料の参照資料とし使用されます。また本来の目的とは異なりますが、DMF の規制当局に登録されているという信頼性とよく整理された医薬原材料の技術文書として活用されることもしばしばです。

１．    DMFの本来の利用方法　（各ガイドラインより抜粋）
１．１　FDA DMF
引用文献１）より抜粋
DMFs can be used to support (but are not substitutes for) applications reviewed by FDA. This guidance focuses on the following submissions to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER): 
• DMFs under 21 CFR 314.420 that are used to support new drug applications (NDAs),  abbreviated new drug applications (ANDAs), and investigational new drug applications (INDs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
• DMFs and other master files under 21 CFR 601.51(a) that are used to support biologics license applications (BLAs) under the Public Health Service Act (PHS Act). 
Additionally, information contained in DMFs can generally be referenced in premarket submissions for devices (e.g., premarket approvals) and animal drugs (e.g., new animal drug applications). Although the focus of this guidance is on the submissions to CDER and CBER described above, in general, FDA believes the contents of this guidance will assist other master file holders in providing complete and up-to-date master files to FDA.

１．２　EU ASMF
引用文献２）より抜粋
An ASMF can only be submitted in support of an MAA or MAV. The relationship between the quality of the active substance and its use in the medicinal product needs to be justified in this MAA or MAV.
The ASMF procedure can be used for the following active substances, including herbal active
substances/preparations. i.e.:
A. New active substances;
B. Existing active substances not included in the European Pharmacopoeia (Ph. Eur.) or the
pharmacopoeia of an EU Member State;
C. Pharmacopeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State.
The ASMF procedure cannot be used for biological active substances, see Annex 5.

１．３　PMDA MF
引用文献３）より抜粋
ＭＦ制度は、医薬品、医療機器及び再生医療等製品の承認審査において、申請者以外の者（ＭＦ登録者）が保有する製造方法等の審査に必要な情報を利用し、また、当該ＭＦ登録者の知的財産を保護することを目的とすると同時に、審査事務の効率化を図るものであること。