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:

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