Drug master file (revision 5)
Old revision·05:02, 23 Nov 2024·HarmReductionHen
| Drug master file | |
|---|---|
| Abbreviation | DMF |
| Contains | Confidential manufacturing and control detail |
| Referenced by | A customer, with a letter of authorisation |
| Not | An approval or a certification |
| Topic infobox · conventions | |
A drug master file (DMF) is a submission to a medicines regulator containing confidential detail about the manufacture, processing and control of a substance. Its purpose is to allow a customer's application to reference that detail without the holder disclosing it to the customer.[1]
A DMF is not an approval. Filing one causes it to be assigned a number and acknowledged; the regulator reviews its content only when an application referencing it is reviewed, and a review finding may be adverse.[1]
Equivalent mechanisms exist elsewhere — the European certificate of suitability to the monographs of the European Pharmacopoeia is the closest analogue, though it differs in being an assessment rather than a repository.[2]
How the mechanism works
[edit]The holder files the document with the regulator. When a customer submits an application using that substance, the holder issues a letter of authorisation permitting the regulator to review the file in support of that application.[1]
The customer never sees the confidential content. This solves a genuine commercial problem: a manufacturer's process is often its principal asset, and disclosure to a customer who may be a competitor's supplier is unattractive.
Because review occurs only in the context of an application, an unreferenced file has never been assessed. A statement that a substance "has a DMF" therefore says that a document exists, not that it has been found adequate.[1]