Saudi Arabia · Saudi Food and Drug Authority · New drugs
Review target
30 working days
official guidance
Legal time limit
-
Not published
Steps
8
11 requirements
Application fee
-
A faster route for new chemical entities and biologics already approved and marketed by both the US FDA and the EMA. The SFDA relies on both agencies' assessment reports. The official target is 30 working days from the date the agency accepts the pathway. New chemical entities and biologics filed within two years of the reference approval, made in one of the listed countries, and identical to the product the reference agency approved.
The official review target is 30 working days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Apply online and pay the fee; 2. Send the designation request and checklist; 3. Eligibility decision (10 days); 4. Business validation (5 days); 5. Evaluation based on the reference agency assessment (15 days); 6. Pricing (5 days); 7. Product licensing (10 days); 8. Moved to another pathway.
Yes. It relies on approvals from European Union, United States (verification, verification).
Outcome: Marketing authorization issued through the SDR system, or transfer to the regular pathway.
Legal basis: Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products, Article 11 (reliance on stringent regulatory authorities)
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 45 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Decisionofficial guidance. Target for the eligibility decision on the designation request. | 10 working days |
| Review targetofficial guidance. Official target that starts when the drug sector accepts the pathway by email. The eligibility decision and applicant time are not counted. Actual times can differ. | 30 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Saudi Arabia: Marketing authorization for a new drug or biologic (regular review), Abridged pathway (approved by US FDA or EMA), Priority review, Breakthrough Medicine Program, Conditional approval, Rolling submission, Orphan drug designation, New Accelerator Program for Drugs in Rare Diseases (NADR), Research and Investigational Drugs (RAID) designation. See all routes on the Saudi Arabia page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (32 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.