Drug master file (revision 13)
Old revision·15:09, 29 Mar 2025·FiveOhThreeB
| Drug master fileRegulatory mechanism | |
|---|---|
| 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]
What a DMF claim establishes
[edit]| Claim | What it establishes |
|---|---|
| A DMF has been filed | A document exists with a number |
| A DMF has been referenced | A regulator has reviewed it for one application |
| A DMF has no outstanding deficiencies | Review occurred and was satisfactory |
| Nothing further | The material in a given vial |
The last row matters here. A DMF describes a process and its controls for a substance intended as an active pharmaceutical ingredient. Material sold as a research chemical is not that substance in the regulatory sense, even where the chemistry is identical.[3]
See also
References
- ^ a b c d United States Food and Drug Administration, Drug Master Files: Guidelines and the published DMF list.
- ^ European Directorate for the Quality of Medicines, Certification of Suitability to the Monographs of the European Pharmacopoeia procedure.
- ^ International Council for Harmonisation, Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (2000).