March 6, 2026
Approximately 5 minutes
Reviewed by Nate Lam, Founder & Director, ElendiLabs
Singapore HSA Drug Master File Submission for Therapeutic Products
Definition and Purpose
A Drug Master File (DMF) is a dossier containing detailed information about specific processes or components used in the manufacturing, processing, and packaging of a drug. It is divided into an Open (Applicant) Part and a Closed (Restricted) Part. Information in the Closed Part is not disclosed to the drug product manufacturer or applicant. HSA reviews DMFs only in conjunction with a product application and does not issue standalone approval. 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. Source: https://www.hsa.gov.sg/therapeutic-products/register/drug-master-file
Who Can Submit
DMF holders submit the DMF and related notifications. Applicants reference the DMF in product applications.
Submission Requirements and Procedures
Notify HSA on the Submission
The DMF holder must first submit the online Notification of DMF Submission Form for new DMF, new Letter of Access, or DMF update. Attach the Letter of Access and Table of Summary of Changes (where applicable). The Letter of Access must state the product name, dosage form, strength, applicant details, and a declaration that the applicant and HSA will be notified of changes affecting quality or safety. HSA assigns a unique DMF number within 20 working days. Source: https://www.hsa.gov.sg/therapeutic-products/register/drug-master-file
What to Submit
Upon receiving the notification, submit the following:
| Type of Submission | DMF holder to submit |
|---|---|
| New DMF | Cover letter stating Response ID and assigned DMF number; Open and closed parts of the DMF in machine-readable PDF format |
| DMF Updates | Cover letter stating Response ID and assigned DMF number; Open and closed parts of the updated DMF in machine-readable PDF format |
| New Letter of Access (without DMF Updates) | Letter of Access with the Notification of DMF Submission Form (no need to resubmit DMF) |
Applicants submit the Open part and a copy of the Letter of Access with the product application. Source: https://www.hsa.gov.sg/therapeutic-products/register/drug-master-file
How to Submit
Reference the HSA-assigned DMF number in the submission package. Folder name: active ingredient name and DMF number (e.g., APINAME_015_1234). Submit via methods outlined in HSA guidance. Refer to Appendix 11 Guideline on Drug Master File and Appendix 11B Sample Letter of Access for DMF. Source: https://www.hsa.gov.sg/therapeutic-products/register/drug-master-file
Fees
No fees are mentioned on the page. Source: https://www.hsa.gov.sg/therapeutic-products/register/drug-master-file
Validity and Updates
DMFs have no fixed validity period; holders must update promptly. Changes impacting quality or safety must be notified to applicants, who then file post-approval variations. Source: https://www.hsa.gov.sg/therapeutic-products/register/drug-master-file
Important Notes
HSA reviews DMFs only with a product application. For existing DMF versions referenced in therapeutic product applications, submit only the Letter of Access with the notification form. Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/therapeutic-products/register/drug-master-file
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Registered Pharmacist · AI Engineer · Director, ElendiLabs
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