Date: 14-Oct-2026
The Saudi Food and Drug Authority (SFDA) has released its new Regulatory Guidance for Submissions and Applications (DS-G-144-V01/261014), taking effect on January 1, 2027. This framework replaces two legacy documents – The Regulatory Framework for Drugs Approval and the Guidance for Submission Guideline—to serve as the primary reference for all product lifecycle activities
Key Scope & Pathways
- Application Types: Covers New Marketing Authorizations (MA), Variations, Renewals, and MA Cessations across human, veterinary, herbal, and health products.
- Submission Formats: Files must be uploaded via the eSDR system utilizing eCTD for human products, CTD for herbal and health items, and VNeeS for veterinary products.
- Special Pathways: Includes provisions for Rolling Submissions, Priority Review, Verification/Abridged pathways, Orphan Drug Designations, Breakthrough Medicines, and the New Accelerator Program for Drugs in Rare Diseases (NADR).
Validation & Performance Targets
- Validation Phase: Submissions undergo automated technical and business validation. Incomplete files are granted a 30-working-day window (maximum two waves) to rectify issues.
Assessment Timelines:
- New MAA (Regular A): 205 working days
- New MAA (Regular B): 250 working days
- Priority Review: 160 working days
- Verification / Abridged / Breakthrough: 60 working days
- Major Variations (Type II): 60 to 140 working days
- Renewals: 40 working days
Source: https://www.sfda.gov.sa/sites/default/files/2026-10/Regulatory%20guidance%20for%20submissions%20and%20applications_V1.0.pdf https://www.sfda.gov.sa/en/guide/19755
