25/26 January 2022
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:
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.