DMF filing procedure in US, Europe and Canada: A Review

  • Krishnasis Chakraborty Long Island University

Abstract

DMF widely known as Drug Master File, is a kind of confidential document which covers all comprehensive, accurate and precise information about Active Pharmaceutical Ingredient (API) or Finished Product Dosage Form (FP). The Drug master file consist of two parts, one the applicant’s part which covers all the information that the license holder needs to review about quality of drug product & other one is the restricted part which covers all the confidential information about the manufacturing process that can only be presented in front of health authorities. A DMF can be used by holder who establishes the file or by one or more parties in support of their files or applications.


The present study is to brief an overview of DMF filing in different countries which are USA, Europe and Canada. In USA, Canada the drug master file is known as DMF and in EUROPE, known as ASMF (Active Substance Master File).

Keywords: Drug master file (DMF), ASMF, Master file (MF), API, IND, NDA, ANDA, FDA, eCTD, LOA

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References

1. Aggarwal P, Badjatya JK. DMF Filing in US, Europe & Canada. International Journal of Drug Regulatory Affairs. 2015; 3(4): 9-17.
2. Yamini SPK, Jain N, Chandra A, Shukla VK, Bansal A and Kumar S. Filing of DMF in US, Canada & Europe. Pharmaceutical Drug Regulatory Affairs Journal. 2019; 2(1): 000108.
3. Shravya K, Swathi P, Snigdha B, Rastrapal D, Suthakaran R. Regulatory Dossiers of ASEM Countries. International Journal of Pharmaceutical Sciences and Research. 2014; 5(8): 3144-51.
4. Gurram I, Kavitha MVS, Reddy N, Nagabhushanam MV. Drug Master File filing in US, Europe, Canada & Australia. Journal of Pharmacy Research. 2017; 16(2): 160-73.
5. Mithun EG, SB Puranik, Naresh Kumar Hasija. An overview of registration of API (DMF) in regulated markets (USFDA, Canada, EU & EDQM (CEP). International Journal of Pharmacy and Pharmaceutical research. 2016; 8(1): 216-31.
6. Akhilesh P, Pramod Kumar TM. DMF Filing in United States, Europe & Japan. World Journal of Pharmacy and Pharmaceutical Science. 2014; 3(3): 323-27.
7. Guidelines for drug master files, CDER FDA [Internet]. FDA; 2020 Jun [cited 2020 Jun 07]. Available from:
http://www.FDA.
8. Guideline for Drug Master Files [Internet]. CDER, FDA; 2020 Jun [cited 2020 Jun 07]. Available from:
http://www.FDA.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122886.htm
9. Guideline for submitting supporting documentation in the drug applications for the manufacture of drug substances”, FDA center for Drugs and Biologics; 1987 Feb.
10. Guidance for Industry Pharmaceutical Quality/ CMC/ Generics. Guidance for Industry [Internet]. FDA; 2017 Oct [cited 2020 Mar 30]. Available from:
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm321884.pdf
11. FDA forms submission requirements [Internet]. FDA; 2020 Mar [cited 2020 Mar 07]. Available from:
https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs
12. The rules governing medicinal products in the European community” Volume III, 11-30; 1992.
13. Draft proposal for European parliament and Council Directive on good manufacturing practice for starting materials of medicinal products and inspection of Manufacturers, European commission; 1999 Feb.
14. Background & Legal Framework [Internet]. EDQM; 2020 [cited 2020 Mar 07]. Available from:
https://www.edqm.eu/en/certification-background-77.html.
15. ASMF filling [Internet]. MHRA; 2020 Jun [cited 2020 Jun 07]. Available from:
http://www.mhra.gov.uk/
16. Authorization Procedures for medicinal products [Internet] European Commission; 2020 [cited 2020 Jun 07]. Available from:
http://ec.europa.eu/health/authorisationprocedures_en.htm
17. European Medicines Agency, EU (2013) Guideline on Active Substance Master File; 2013.p. 1-22.
18. Authority of the Ministry of Health, Health Canada (2017) Guidance Document Master Files (MFs)-Procedures & Administrative Requirements; 2017.p. 1-32.
19. Health Canada NOTICE file number: 08-124317-334 [Internet]. Health Canada; 2020 Jun [cited 2020 Jun 07]. Available from:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfbdgpsa/pdf/prodpharma/draft_ebauche_dmf_fmm_guide_ld-eng.pdf.
20. Guidance Document Preparation of Drug Regulatory Activities in the “Non-eCTD Electronic-Only” for Health Products and Food Branch: Revised Date 03rd February 2016 [Internet]. Health Canada; 2016 Feb [cited 2020 Mar 07]. Available from:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guideld/ctd/gd_prep_non_ectd_lg-eng.pdf.
21. Drug and Health Products: Notice - Re: Preparation of Drug Master File (DMF) in "Non-eCTD Electronic-Only" [Internet]. Health Canada; 2020 Jun [cited 2020 Jun 07]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announceannonce/notice_dmf_prep_fmm_avis_non_ectd-eng.php.
22. eCTD TECHNICAL CONFORMANCE GUIDE Technical Specifications Document October 2015 [Internet]. FDA; 2015 Oct [cited 2020 Jun 07]. Available from:
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/Electronic_Submissions/UCM465411.pdf.
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How to Cite
Chakraborty, K. “DMF Filing Procedure in US, Europe and Canada: A Review”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 2, June 2020, pp. 7-14, doi:10.22270/ijdra.v8i2.385.