Regulatory requirements for Drug master file in context to Canada and Australia

  • Meghna Danej gujarat
  • Ronak Dedania
  • Sanket Gandhi
  • Juhi Randeria
  • Kankrej Gaurav


Drug Master Files are required in most countries as supporting documents for the registration of drug products. DMFs generally contain information pertaining to the chemistry, manufacturing and controls (CMC) sections of the drug submission and reflect the drug’s identity, strength, purity and quality. Canada and Australia which are consider as highly regulated markets (HRMs). In CANADA, DMF filing was done through New Drug Submission (NDS) for both drugs and biologic products. They use MF terminology for DMF which contain four types of MASTER FILE- ASMFs, CCS MFs, Excipient MFs, Drug product MFs. In AUSTRALIA different application processes and regulatory requirements apply depending on the type of therapeutic goods that is applied. They consist of eight phase for DMF registration. Where EU guidelines adopted in Australia include references to EU legislation. Now from 2016 onwards most of the regulated countries will use eCTD or their electronic format for their DMF submission. Compare DMF regulatory requirements in the above-mentioned countries so that reader can have clear idea on how to file DMF.

Keywords: DMF, HRMs, NDS, ASMFs, CCS, EU, eCTD


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1. Drug Master File: Guidelines [Internet]. US FDA; 2005 [Updated 2005 Mar 11] [cited 2018 Jan]. Available from:
2. Akram MV, Nagarjuna, D Ramaiah M, Nagabhushanam M and Venkateswarlu B. Regulatory Requirements of Drug Master Files by Food and Drug Administration (USA). European Medicines Agency (Europe) and Health Canada (Canada) and their Comparison. Int. Glob. Phrm. Sci. 2014; 2220-24.
3. Drug Master File- Wikipedia [Internet]. Wikipedia; 2018 Mar [cited 2018 Mar 26]. Available from:
4. 2011 Fall Report of the Auditor General of Canada [Internet].2011 [cited 2018 Jan 18] Available from:
5. Therapeutic Goods Administration (TGA) [Internet]. Australia: TGA [cited 2018 Mar 12]. Available from:
6. Draft Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements. [Internet]. Health Canada; 2016 Feb 15[cited 2018 Feb 10]. Available from:
7. Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format [Internet]. Health Canada; 2015 May [cited 2018 Feb 21]. Available from: services/ drugs-health-products/drug-products/ applications-submissions/guidance-documents/ common-technical -document/preparation-drug-regulatory-activities-common-technical-document -format.html
8. Mallu UR, Kuraka AK and Bapatu HR. Pharmaceutical drug products approval procedure in Australia. Int. J. Sat. 2013; (3):690-705.
9. Gurram I, Kavitha MV, Reddy N, Nagabhushanam MV. Drug Master File Filing in US, Europe, Canada and Australia. J. Phrm. Res. 2017; p 160.
10. Raghucharan Y, Reddy LM, Bukke VN, Sundaram AM and Reddy JP. Regulatory Requirements for the Approval of Generic Drugs and Compilation of Dossier for Australia (TGA). Int. J. Ph. 2014; 201-6.
11. CTD Module 1 Administrative information and prescribing information for Australia [Internet]. Australia TGA; 2015 Jul [cited 2018 Feb 24]. Available from:
12. Australian regulatory guidelines for prescription medicines (argpm) [Internet]. Australia TGA; 2018 [cited 2018 Feb 11]. Available from:
13. Guidance for Industry M4Q: The CTD — Quality [Internet]. ICH; 2001 Aug [cited 2018 Feb 14]. Available from:
14. ICH M4Q - Common Technical Document for the Registration of Pharmaceuticals for human use quality [Internet]. London: EMEA; 2003 Feb 20 [cited 2018 Feb 17]. Available from:
15. ICH M4E - Common Technical Document for The Registration of Pharmaceuticals for human use efficacy [Internet]. London: EMEA; 2003 Feb 20 [cited 2018 Feb 17]. Available from:
16. ICH M4S - Common Technical Document for The Registration of Pharmaceuticals For human Use: Safety [Internet]. London: EMEA; 2003 Feb 20 [cited 2018 Feb 17]. Available from:
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How to Cite
Danej, M., R. Dedania, S. Gandhi, J. Randeria, and K. Gaurav. “Regulatory Requirements for Drug Master File in Context to Canada and Australia”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 2, June 2018, pp. 41-47, doi:10.22270/ijdra.v6i2.236.