DMF FILING IN US, EUROPE AND CANADA

  • Pooja Agarwal
  • J. K. Badjatya

Abstract

A Drug Master File or DMF is a reference source that provides drug evaluator’s confidential information not available to drug product manufacturer about the specific process and components used in the manufacturing, processing and packaging of a drug meant for Human/Animal use. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, or amendments and supplements to any of these.

Keywords: DMF, ICH CTD, AP. RP, FDA, QOS, CMC.

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References

1. Guideline for Drug Master Files [Internet]. CDER, FDA; 2005 Mar[cited 2015 Nov 15]. Available from:
http://www.FDA.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122886.htm
2. Guidelines for drug master files, United States, Food and Drug Administration [Internet]. USFDA; 2011 Nov 14 [cited 2015 Nov 09]. Available from:
www.FDA.gov/downloads/Drugs/.../UCM279666.pdf
3. Guidelines for drug master files, CDER FDA [Internet]. FDA; 2015 [cited 2015 Nov 12].
Available from:
http://www.FDA.gov/cder/guidancde/DMF.htm.
4. Forms and Submission requirements [Internet]. FDA; 2015 Nov [cited 2015 Nov 08]. Available from:
http://www.FDA.gov/Drugs/DevelopmentApprovalProcess/Forms Submission
5. Requirements/Drug Master Files DMF’s [Internet]. FDA; 2013 Feb 11 [cited 2015 Nov 08].
Available from:
www.FDA.gov/downloads/Drugs/.../UCM339118.pdf
6. Classifying resubmission of original NDAs, BLAs, and efficacy supplements in response to complete response letters. [Internet]. [Cited on 4 April 2013].
[Internet] FDA; 1998 May 1 [cited 2015 Nov 15]. Available from:
http://www.FDA.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm04.pdf
7. Compliance Regulatory [Internet]. FDA; 2013 June [cited 2015 Nov 12]. Available from:
http://www.FDA.gov/downloads/Drugs/Guidance
8. DMF fees in USA [Internet] Washington, DC: GPO; 2013 [cited 2015 Sept 03]. Available from:
http://www.gpo.gov/fdsys/pkg/FR-2013-08- 02/pdf/ 2013 -18625.pdf.
9. ASMF filling fees [Internet]. MHRA; 2014[cited 2015 Nov 02]. Available from:
http://www.mhra.gov.uk/
10. Canada DMF fees [Internet]. Health Canada; 2013[cited 2015 Nov 03]. Available from:
http://www.hcsc.gc.ca/dhpmps/prodpharma/applicdemande/form/DMFf_fmmf_2013-eng.php
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How to Cite
Agarwal, P., and J. K. Badjatya. “DMF FILING IN US, EUROPE AND CANADA”. International Journal of Drug Regulatory Affairs, Vol. 3, no. 4, Feb. 2018, pp. 9-17, doi:10.22270/ijdra.v3i4.172.

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