A Drug Master File (DMF) is a reference that provides information about specific processes or components used in the manufacturing, processing, and packaging of a drug. The DMF contains information of a proprietary nature that is not available to the drug product manufacturer or to the applicant of a product registration submission.
You may submit a DMF as part of your application dossier to support your registration of a therapeutic product or medical device containing a drug substance.
You will need to submit all DMF documents in softcopy in a CD/DVD. The original hardcopies are not required. Ensure that the DMF is linked to either a therapeutic product application or a medical device application.
The DMF is divided into two parts: an open (or applicant’s) part and a closed (restricted) part. The following documents are part of the requirements for an application making reference to a DMF:
From the applicant:
- Letter of Access from the DMF holder, authorising us to refer to the DMF in support of the application for a drug product. Refer to our sample Letter of Access298 KB for reference.
- Open part of the DMF in PDF format.
From the drug substance manufacturer (DMF holder):
- Scanned, colour copy of the signed and completed DMF submission form271 KB.
- Open and closed parts of the DMF in PDF format in a CD/DVD.
- Scanned, colour copy of the Letter of Access.
The Letter of Access should state the following:
- Product name, dosage form and product strength of the drug product.
- Name, address and email contact of the local applicant.
- Declaration that the local applicant and us will be notified of any change in the drug substance specification, manufacturing process, or any other aspects that will likely affect the product's quality or safety.
Note: If a therapeutic product or medical device application makes reference to a currently-listed DMF, the scanned, colour copy of the Letter of Access should be provided by the DMF holder. The open part of DMF and a copy of the Letter of Access should be submitted by the applicant.
How to submit a DMF
The DMF holder should submit the DMF directly to us to the following address to maintain confidentiality of the contents:
Therapeutic Products Branch
Health Sciences Authority
11 Biopolis Way
Level 11, Helios
- The confidential information in the DMF will not be disclosed to any third party without written authorisation from the DMF Holder.
- A DMF number will be issued upon receipt of complete information. DMF holder and applicant should refer to this DMF number for future correspondence.
- For applications submitted under the verification route, applicants who are unable to obtain complete unredacted assessment report for the DMF can submit the DMF holder's authorisation form to us before the submission of the registration application and we will help to facilitate the retrieval of the reports.
Updates to DMF
When there are updates to the DMF, the DMF holder must provide the following:
The DMF holder must inform the local applicant to file a post-approval variation if changes to the DMF will result in a post-approval variation to the drug product.