A Drug Master File (DMF) is a dossier that contains detailed 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) Part and a Closed (Restricted) Part. Information in the Closed Part is not disclosed to the drug product manufacturer or the applicant submitting the product application.
HSA reviews DMF only in conjunction with a product application. HSA does not issue standalone approval for DMF.
DMF Holders and applicants are responsible for maintaining and updating the DMF and registration dossier. DMF Holders must promptly notify product registrants of any changes that may impact product quality or safety, and registrants must then file appropriate post-approval variations.
Notify HSA on the Submission
The DMF Holder must first submit the online Notification of DMF Submission Form (“notification form”) for:
- New DMF
- New Letter of Access
- DMF update
The DMF Holder must attach the Letter of Access and Table of Summary of Changes (where applicable) with the form.
The Letter of Access should state the following:
- Product name, dosage form and product strength
- Name, address and email contact of the applicant
- Declaration that the applicant and HSA will be notified of changes that will likely affect the product’s quality or safety.
HSA will assign a unique DMF number to each DMF. The DMF Holder and applicant will be informed of the assigned DMF number, where applicable, within 20 working days and to proceed with the submission as described below.
What to submit
Upon receiving the notification from HSA, submit the following documents.
| Type of Submission | DMF holder to submit: |
|---|
| New DMF | - A cover letter stating the Response ID obtained from the Notification Form and the assigned DMF number
- Open and closed parts of the DMF in machine-readable PDF format
|
| DMF Updates | - A cover letter stating the Response ID obtained from the Notification Form and the assigned DMF number
- Open and closed parts of the updated DMF in machine-readable PDF format
|
| New Letter of Access (without DMF Updates) | If a therapeutic product application references an existing DMF version, submit the Letter of Access with the Notification of DMF Submission Form. You do not need to submit the DMF again. |
Once HSA receives the complete DMF, we will notify both the DMF Holder and applicant, where applicable. The applicant may then proceed to submit the following with the product application.
| Applicant to submit: |
|---|
· Open part of the DMF in machine-readable PDF format
· A copy of the Letter of Access
|
How to submit
The DMF holder and applicant are to reference the HSA-assigned DMF number in the submission package and subsequent correspondences. The folder should state the active ingredient name and assigned DMF number.
E.g. APINAME_015_1234
Submit the required documents via one of the following methods:
| Submission Mode | Applicable to | Details |
|---|
| PRISM | Applicant only | - |
| CD/DVD | DMF Holder & Applicant | Send CD/ DVD to:
Therapeutic Products Branch
Health Sciences Authority
11 Biopolis Way,
Level 11, Helios
Singapore 138667 |
| EasiShare | DMF Holder & Applicant | Refer to the following to prepare your submission:
|
Refer to our Guidance on Therapeutic Product Registration for more details: