Thursday, March 14, 2013

Types of DMF (Drug Master File)

The types of DMFs are:
  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III Packaging Material
  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V FDA Accepted Reference Information

As per geography -
  • Active Substance Master File (ASMF) procedure, commonly known as the European Drug Master File 
  • EU Authority (EMEA) does not give DMF number.
  • If the API is in EU Pharmacopoeia, EMEA can accept EDMF filing and issue a “Certificate of Suitability” for it.
  • If the API is not in EU, EMEA would not accept DMF filing alone. 
  • The EDMF procedure can be used for the following active substances, including herbal active substances/preparations (except biological active substances,), i.e.: New active substances 
  • Existing active substances not included in the European Pharmacopoeia (Ph. Eur.) or the pharmacopoeia of an EU Member State 
  • Pharmacopoeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State 
Canada DMF

A Canadian DMF, like a DMF submitted to the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER), is a submission that may be used to provide detailed information about facilities, processes, or articles used in the manufacture, processing, packaging, and storage of human drug products. 

Australia DMF

Where a drug substance used in the manufacture of a medicine is sourced from a third party 
manufacturer, data on its manufacture, quality control and stability may be submitted via a Drug Master File (DMF). The relevant European guidelines for the European Drug Master File Procedure, which has been adopted by the Therapeutic Goods Administration (TGA), are available from the TGA web site1. 
A DMF using the United States format is acceptable if a DMF formatted according to the Common Technical Document (CTD) or the older European format is not available.

Details of DMF - 




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