Journal of Pharmaceutical Research

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Drug Master File Filing in US, Europe, Canada and Australia


Affiliations
1 Department of Pharmaceutical Management and Regulatory Affairs, Hindu College of Pharmacy, Amravati Road, Guntur, AP, India
 

Purpose: A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation, it is submitted solely at the discretion of the DMF holder. The DMF contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product. The present work gives the Detailed idea on how to file Drug Master File in US, EUROPE, CANADA, AUSTRALIA.

Approach: A Drug Master File is a submission of information to the FDA to permit the FDA to review this information in support of a third party's submission without revealing the information to the third party. In US, DMF filing was done through NDA for drugs, ANDA for generics and BLA for Biologics. In Europe, DMF filing was done through MAA via centralized procedure for eligible products and for other products via decentralized procedure was used. In CANADA, DMF filing was done through NDS for both drugs and biologic products, where as in AUSTRALIA different application processes and regulatory requirements apply depending on the type of therapeutic goods that is applied.

Findings: This gives you clear vision on how to file Drug master file in US, EUROPE, CANADA and AUSTRALIA. This paper also gives you the comparison of DMF fling procedure in the above-mentioned countries so that reader can have clear idea on how to file DMF and different concerns on DMF among the above counties.

Conclusion: The DMF contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, Packaging and the cGMP status of any Drug product for humans. The content and the format for Drug Master File is used to obtain marketing Authorization. The main objective of the DMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a marketing authorization grant. Now from 2016 onwards most of the regulated countries will use eCTD or their electronic format for their DMF submission.


Keywords

DMF, FDA, CDR, CMC, CEP, LOA, TGA, ACPM, ACSOM, NDS, MAA, ANDA.
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  • Guidelines for Drug Master Files [Internet]. CDER, FDA; 2005 Mar[cited 2015 Nov 15]. Available from: http://www.FDA.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm122886.ht m (Accessed on 15th march 2017)

  • Guidelines for drug master files, United States, Food and Drug Administration [Internet]. USFDA; 2011 Nov 14 [cited 2015 Nov 09]. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM279666.pdf (Accessed on 15th March 2017)

  • Guidelines for drug master files, CDER FDA [Internet]. FDA; 2015 [cited 2015 Nov 12]. Available from: http://www.FDA.gov/cder/guidancde/ DMF.htm (Accessed on 20th march 2017).

  • Forms and Submission requirements [Internet]. FDA;2015 Nov [cited 2015 Nov 08]. Available from: https://www.fda.gov/Drugs/Development ApprovalProcess/ucm090361.htm (Accessed on 20th march 2017)

  • Requirements/Drug Master Files DMF's [Internet]. FDA; 2013 Feb 11 [cited 2015 Nov 08]. Available from: https://www.fda.gov/downloads/drugs/ developmentapprovalprocess/smallbusinessassistance/ucm339118.pdf (Accessed on 21st march 2017)

  • Guideline on Active Substance Master File Procedure - Europa.eu Available from http://www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2012/07/WC500129994.pdf (Accessed on 21st march 2017)

  • Guideline on the European Drug From http://www.gmpcompliance.org/gmp-news/guideline-on-the-european-drug-masterfileprocedure-updated (Accessed on 25th march 2017)

  • Draft Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements. Available from http://www.hcsc.gc.ca/dhp-mps/consultation/drug-medic/draft_guide_mf_fm_ ld_ebauche- eng.php (Accessed on 30th march 2017).

  • Prescription medicine registration process , for the application lodged under the process of prescription registration process, Australian government, version 2 Available from https://www.tga.gov.au/ sites/default/iles/pm-argpm-process.pdf (Accessed on 30th march 2017)

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Abstract Views: 221

PDF Views: 62




  • Drug Master File Filing in US, Europe, Canada and Australia

Abstract Views: 221  |  PDF Views: 62

Authors

Indu Gurram
Department of Pharmaceutical Management and Regulatory Affairs, Hindu College of Pharmacy, Amravati Road, Guntur, AP, India
M. V. S. Kavitha
Department of Pharmaceutical Management and Regulatory Affairs, Hindu College of Pharmacy, Amravati Road, Guntur, AP, India
Nagarjuna Reddy
Department of Pharmaceutical Management and Regulatory Affairs, Hindu College of Pharmacy, Amravati Road, Guntur, AP, India
M. V. Nagabhushanam
Department of Pharmaceutical Management and Regulatory Affairs, Hindu College of Pharmacy, Amravati Road, Guntur, AP, India

Abstract


Purpose: A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation, it is submitted solely at the discretion of the DMF holder. The DMF contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product. The present work gives the Detailed idea on how to file Drug Master File in US, EUROPE, CANADA, AUSTRALIA.

Approach: A Drug Master File is a submission of information to the FDA to permit the FDA to review this information in support of a third party's submission without revealing the information to the third party. In US, DMF filing was done through NDA for drugs, ANDA for generics and BLA for Biologics. In Europe, DMF filing was done through MAA via centralized procedure for eligible products and for other products via decentralized procedure was used. In CANADA, DMF filing was done through NDS for both drugs and biologic products, where as in AUSTRALIA different application processes and regulatory requirements apply depending on the type of therapeutic goods that is applied.

Findings: This gives you clear vision on how to file Drug master file in US, EUROPE, CANADA and AUSTRALIA. This paper also gives you the comparison of DMF fling procedure in the above-mentioned countries so that reader can have clear idea on how to file DMF and different concerns on DMF among the above counties.

Conclusion: The DMF contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, Packaging and the cGMP status of any Drug product for humans. The content and the format for Drug Master File is used to obtain marketing Authorization. The main objective of the DMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a marketing authorization grant. Now from 2016 onwards most of the regulated countries will use eCTD or their electronic format for their DMF submission.


Keywords


DMF, FDA, CDR, CMC, CEP, LOA, TGA, ACPM, ACSOM, NDS, MAA, ANDA.

References