Saudi Arabia · Saudi Food and Drug Authority · New drugs
Review target
40 working days
official guidance
Legal time limit
-
Not published
Steps
7
4 requirements
Application fee
-
A designation, in force since July 2026, for investigational medicines not yet authorized anywhere whose sponsors commit to run a clinical trial in Saudi Arabia. Designated products get a product manager, scientific advice and pricing support, and later qualify for priority review and rolling submission, and possibly conditional approval. New drugs and biologics in phase I, II or III that will be tested in Saudi Arabia and meet an unmet need.
The official review target is 40 working days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Pre-designation meeting (optional); 2. Submit the RAID application; 3. Validation (15 days); 4. Fix deficiencies (clock stopped); 5. Evaluation (40 days); 6. Decision letter (5 days); 7. Clinical trial application.
Outcome: RAID designation, followed by a clinical trial application and later an expedited marketing application.
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 105 days end to end with the official step targets, of which up to 90 days are clock stops (time the applicant uses to answer). 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
| Validationofficial guidance. Target to confirm scope and format. | 15 working days |
| Review targetofficial guidance. Target for the evaluation of a validated designation file. Applicant time is not counted. Actual times can differ. | 40 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, New Accelerator Program for Drugs in Rare Diseases (NADR). 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 (18 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.