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

Abstract

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.