Saudi Food and Drug Authority publishes Drug Master File Guidance

This year in August, the regulatory authority of Saudi Arabia published a guideline entitled "Drug Master File (DMF): Guidance for Submission". The document describes the formal prerequisites to be fulfilled to ensure the successful submission of a DMF. The following elements have to be part of a DMF:

  • Cover letter - This letter shall include all technical-formal information like for example the name of the API, trade name, name and address of both the manufacturer and the DMF holder, registration or reference number.
  • Letter of access: authorisation to review and reference the DMF.
    The same information as in the cover letter should also be indicated here. If the API is manufactured at different manufacturing sites, all sites have to be listed.
  • Formal requirements for the DMF: the DMF must be written either in English or Arabic. Only one electronic-based copy - a CD - should be submitted. If the data volume exceeds 750 MB, a DVD should be used.

In the context of this DMF Guideline, there is another important document entitled "Guidance for Submission" published by the SFDA in March 2014 in the updated version 4.0. The document contains further technical details about the storage media to be used for all submissions made to the SFDA, e.g. security requirements, password and virus protection, etc. These requirements should also be considered for the submission of Drug Master Files.

Further regulations and guidelines of the Saudi Authority relevant for authorisation can be found on the website of the SFDA.

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