Saudi Arabia · Saudi Food and Drug Authority · New drugs
Review target
60 working days
official guidance
Legal time limit
-
Not published
Steps
8
5 requirements
Application fee
-
A voluntary program for new medicines for serious or life-threatening conditions with unmet needs that are not yet registered anywhere. A scientific committee reviews the request, gives early advice, and the agency targets a 60 working day scientific assessment once the full file is in. Unregistered new medicines that meet all four criteria, from the end of phase 2 onward.
The official review target is 60 working days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Designation request; 2. Scientific committee review (30 days); 3. Designation decision; 4. Scientific advice when data are incomplete; 5. Submit the application; 6. Scientific assessment (60 days); 7. Answer questions (clock stopped); 8. Marketing authorization decision.
Outcome: Designation with early advice, then a marketing authorization decision.
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 180 days end to end with the official step targets, of which up to 60 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
Targets, not actual review times
| Decisionofficial guidance. Usual time for the committee review of the designation request. | 30 working days |
| Review targetofficial guidance. Target for the scientific assessment after the file is submitted. Applicant time is not counted. Actual times can differ. | 60 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), Verification pathway (approved by both US FDA and EMA), Abridged pathway (approved by US FDA or EMA), Priority review, 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 (20 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
What the applicant must provide or meet