Saudi Arabia · Saudi Food and Drug Authority · New drugs
Review target
-
Not published
Legal time limit
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Not published
Steps
5
6 requirements
Application fee
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A program for medicines for rare diseases with unmet needs, in force since September 2026. Designated products get a dedicated product manager, scientific advice, and access to conditional approval, priority review and rolling submission. The agency also accepts flexible evidence, may waive some quality data, and eases site inspection. The eligibility review target is 20 working days. Medicines and biologics for rare diseases, at any stage of development or already authorized abroad, before the marketing application in Saudi Arabia.
1. Pre-submission meeting; 2. Submit the NADR request; 3. Evaluation of eligibility (20 days); 4. Decision letter; 5. Submit the marketing application.
Outcome: NADR designation with program incentives. The marketing application follows within about 6 months.
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 203 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 review of NADR eligibility and any parallel orphan designation request, from a complete submission. | 20 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, Breakthrough Medicine Program, Conditional approval, Rolling submission, Orphan drug designation, 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 (17 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.