Drug Master Files (DMFs) serve as the primary basis for the Saudi Food and Drug Authority (SFDA) to evaluate the quality, safety, and efficacy of the Active Pharmaceutical Ingredient (API) while maintaining the confidentiality of the manufacturer’s proprietary data. Whether you are a manufacturer of active ingredients, excipients, or packaging materials, or a sponsor dependent on a third-party supplier, filing a well-prepared DMF is mandatory to support drug registration in Saudi Arabia.
This article explains the requirements for DMF submissions, including content requirements, format standards, and strategic considerations for local and international stakeholders.
Table of contents
Definition
A Drug Master File is a set of confidential documents, submitted to the regulatory authority, such as the SFDA, by the API manufacturer of a drug substance, containing detailed information on the manufacturing process, quality control, and other relevant aspects of the drug substance. It is a mandatory part of the drug dossier and plays an important part in the registration process of a drug product.
Scope
SFDA does not categorize DMFs by type but instead by the following information related to:
- Drug Substances commonly known as Active Pharmaceutical Ingredients – APIs
- Drug Substance Intermediates
- Materials used in preparation, e.g., excipients and packaging components.
Key Considerations for DMF Submission
- When filing a DMF with the SFDA, ensure your files are complete and compliant with applicable regulations. It is important to note that SFDA does not accept the DMF submission alone. Instead, it must be part of a finished product dossier submitted by a Marketing Authorization Holder (MAH). The DMF is represented in Part 3.2 S of the dossier.
- DMF should include the DMF form and letter of access.
- 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 the SFDA with a Letter of Access to permit the SFDA 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), trade name, DMF holder name, and DMF Version number/Date. - Manufacturer Details:
Name and address of manufacturer (if different from DMF holder name). - Authorized Signatory:
Typewritten name, title, and signature of the authorized representative issuing the Letter of Access. - DMF Status Confirmation:
A confirmation letter shall be submitted if the DMF has not changed for the last five years.
The Letter of Access and DMF form should be on the company’s letterhead.
Important Notes
- A list of all manufacturing sites must be provided.
- All supporting documents, such as certificates and approval letters, must be in English or Arabic.
- DMF must be in PDF format.
- DMF application form should be in Word format.
DMF Changes
If any changes occur in the drug product Marketing Authorization Holder (MAH), the manufacturer must submit a variation and report the changes 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
Contributed by the PharmaKnowl regulatory affairs team, based in Riyadh. Written and reviewed by our SFDA-experienced consultants.
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