Difference between DMF and Dossier
As I know, Drug master file has information of the manufactured product while dossier is an application submitted to the regulatory agencies.
1 Like
Drug Master file is part of 3.2.S of the dossier which contains information regarding API only where as the dossier is submitted for the finished pharmaceutical product.
tnx to you
The Drug Master File (DMF) is a typical term used for the registration of different ingredients with USFDA.
There are five types of DMFs that can be registered with USFDA as follows.
*Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
Type II: Drug Substance, Drug Substance Intermediate, and material used in their Preparation, or preparation of drug products
Type III: Packaging Material
Type IV: Excipient, Colorant, Flavour, Essence, or Material Used in Their Preparation
Type V: FDA-Accepted Reference Information
- Type I DMFs were discontinued in the year 2000 but the numbering of the other DMF types has not changed.
Please note that DMF is never approved or rejected by the USFDA.
A Drug Master File (DMF) is a submission to the Food and Drug Administration (USFDA) that is 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 information contained in the DMF may be used to support USDFA submitted documents such as
- Investigational New Drug Application (IND),
- a New Drug Application (NDA),
- an Abbreviated New Drug Application (ANDA), another DMF,
- an Export Application, or
- amendments and supplements to any of these.
Term ASMF (Active Substance Master File) is used for API registration with the European Regulatory authorities. This is similar to DMF.
Term ‘Dossier’ is a generic term used by several regulatory authorities. A dossier is a document of the drug product that is a compilation of administrative and technical information (Like labeling, CMC data - Chemistry, Manufacturing, Control, Clinical and Non-clinical data, etc.) for submission to Regulatory authorities for seeking marketing approval.
Product dossiers are either approved or rejected by regulatory authorities for getting Marketing authorization. While DMFs are just referred by the customers and Regulatory authority-USFDA for seeking information of APIs, and other ingredients to be used in their drug product.
This topic was automatically closed 10 days after the last reply. New replies are no longer allowed.