Saudi Arabia · Saudi Food and Drug Authority · New drugs
Review target
168 working days
official guidance
Legal time limit
-
Not published
Steps
7
5 requirements
Application fee
-
Priority review cuts the official review target by 40 percent. It is open to new drugs and biologics for serious conditions or unmet needs, to the first biosimilar of an innovator, and to medicines on the national list of unavailable products. The target is 168 working days for new drugs registered with a stringent authority and 243 working days otherwise. Request it before filing a new drug or biologic for a serious or life-threatening condition, a first biosimilar, or an unavailable medicine.
The official review target is 168 working days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Request priority review; 2. Designation decision (15 days); 3. Submit the file; 4. Business validation (10 days); 5. Priority evaluation (147 days); 6. Pricing (12 days); 7. Product licensing (9 days).
Outcome: Marketing authorization on the regular evidence standard, with a shorter review target.
Legal basis: Law of Pharmaceutical and Herbal Establishments and Products and its Implementing Regulations; Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products
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 193 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
Targets, not actual review times
| Decisionofficial guidance. Target for the decision on a priority review request for a new drug or biologic. | 15 working days |
| Review targetofficial guidance. Official target for new drugs and biologics registered with a stringent regulatory authority. It is 243 working days for those not registered. Business validation and applicant time are not counted. Actual times can differ. | 168 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), Registration of a biosimilar, Verification pathway (approved by both US FDA and EMA), Abridged pathway (approved by US FDA or EMA), 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 (22 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
What the applicant must provide or meet