Saudi Arabia’s (SFDA) Guide on Regulatory Framework for Drug Registration, Variation or Renewals

Saudi Arabia’s (SFDA) updated Guide on Regulatory Framework for Drug Registration, Variation or Renewal

The Drug Sector in Saudi Food & Drug Authority (SFDA) has developed this administrative document to provide assistance for stakeholders on how to submit applications for various types of drug products and the procedure to authorize the applications.

Besides the Market Authorization Application (MAA) of various types of drug products, it also describes variations applications and renewal of MAA.

Also, various application forms and timeframe for processing applications to marketing the product in Saudi Arabia are also included in this document.

This framework applicable to all types of drug product submitted for registration, variation or renewal and details elaborately on New MAA online submission, Validation, Inspections Assessment, Licensing, etc.

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