About the Author
Regulatory Editor
Published by regulatory affairs team in PharmaKnowl, Riyadh office.
Drug Master Files (DMFs) form the primary basis for evaluating the quality of the active pharmaceutical ingredient by the SFDA, without requiring companies to disclose all their sensitive or proprietary information. Whether you are a manufacturer of active ingredients, excipients, or packaging material supplies or a sponsor dependent on a third-party supplier, filing a well-prepared DMF is mandatory to support drug registration in Saudi Arabia.
This overview explains the SFDA’s existing expectations regarding DMF submissions, including content requirements, format standards, and strategic considerations that local and international stakeholders should consider.
Table of contents
Definition
A Drug Master File is a confidential document submitted to the regulatory authority, such as the SFDA, containing detailed information on the manufacturing process, quality control, and other relevant aspects of the drug product. It does not qualify for marketing authorisation but supports the registration process by providing essential data while protecting proprietary information.
Scope
SFDA does not categorise DMFs by type but instead receives Drug Master Files supporting the following product components of pharmaceutical preparations:
- Drug Substances (commonly known as Active Pharmaceutical Ingredients – APIs)
- Drug Substance Intermediates
- Materials used in preparation (e.g., excipients and packaging components).
Core Requirements for DMF Submission
When filing a DMF with SFDA, ensure your files are complete and compliant with the ICH and related regulations. It is important to note that SFDA does not accept the submission of a DMF file alone. Instead, it must be part of a finished product dossier submitted by a marketing authorization holder (MAH). The MDF is represented in the 3.2 S part of the dossier.
DMF Restricted Part
The restricted part of the DMF must be submitted in soft copy via SFDA’s secure link, or sometimes by email to the authority.
Letter of Access
The holder of the DMF must provide a Letter of Access for the SFDA to allow them to review the restricted parts. This letter is required when submitting the open parts.
The Letter of Access should have the following main details:
- Submission Details:
Type (new, renewal, resubmission or variation), procedure (National or GCC-DR) and reference or registration number. - Substance and Product Information:
Active Substance Name, Pharmacopeial Reference (For Example, USP, BP), and DMF Version/Date. - DMF Holder and Manufacturer Details:
Name and address of DMF holder and manufacturer (if different). - Authorised Signatory:
Typewritten name, title, and signature of the authorised representative issuing the Letter of Access. - DMF Status Confirmation:
A confirmation letter shall be submitted if the DMF has not changed for five years.
The Letter of Access and DMF form should be on the company’s letterhead.
DMF Changes
If any changes occur in the drug product MAH, the manufacturer must submit a variation and report them to the SFDA in due time.
Registration Support
PharmaKnowl supports end-to-end document planning, including eCTD formatting and Letter of Access compliance, ensuring fast, SFDA-ready submissions.
Contact us to streamline your approval process and avoid delays.
About the Author
Regulatory Editor
Published by regulatory affairs team in PharmaKnowl, Riyadh office.
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