DMF and CTD

1. Type II DMFs may be submitted in the format for "Drug substance" in the "Guidance for Industry M4Q: The CTD - Quality". (Category 3)

http://www.fda.gov/cder/guidance/4539q.pdf

2. The organization of CTD (M4) [日本語]

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129873.pdf

3. Other MF references:

http://www.fda.gov/Cber/ctd/ctd.htm

http://www.fda.gov/cder/ogd/anda_checklist.doc (ANDA)

http://www.who.int/prequal/trainingresources/pq_pres/Tallinn-Oct07/Dossier_structure_en.ppt

http://www.tga.gov.au/docs/html/eugctd.htm (Australia)

http://caivs.blogspot.com/2008/02/japanese-master-file-system.html (Japan)