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.
A DMF is generally divided into two parts: an open (or applicant’s) part and a closed (restricted) part. The closed part contains information of a proprietary nature that is not available to the drug product manufacturer or to the local 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. Ensure that the DMF submitted is linked to a product registration application.
Documents required
You will need to submit the following documents.
From the local applicant:
- Open part of the DMF
- A copy of the Letter of Access
- A copy of the acknowledgement email from HSA on the receipt of the Letter of Access
From the DMF holder:
- Online DMF Submission Form
- A cover letter stating the Response ID obtained from the Online DMF Submission Form
- Open and closed parts of the DMF
- Colour scanned 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
For applications submitted under the verification route, local 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:
- Online DMF Submission Form
- A cover letter stating the Response ID obtained from the Online DMF Submission Form
- Table of summary of changes
- The updated sections of the DMF
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 application to the drug product.
New Letter of Access without updates to DMF
If a therapeutic product or medical device application makes reference to an existing DMF version, the colour scanned copy of the Letter of Access may be submitted by the DMF holder via the Online DMF Submission Form. The open part of the DMF and a copy of the same Letter of Access should be submitted by the local applicant as part of the application dossier.
How to submit
From the local applicant:
- Submit the documents required in PDF format as part of the application dossier.
From the DMF holder:
- DMF documents may be submitted to HSA in PDF format via the following methods:
1) In a CD/DVD to the following address:
Therapeutic Products Branch
Health Sciences Authority
11 Biopolis Way
Level 11, Helios
Singapore 138667
2) Via third-party cloud-based file exchange software (EasiShare).
i. Prepare your documents:
ii. Request for access (click here) to EasiShare for dossier submissions.
A DMF number will be assigned upon receipt of the complete set of DMF documents. The DMF holder and local applicant should refer to the assigned DMF number for future correspondence.