Saudi Arabia · Saudi Food and Drug Authority · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
3 requirements
Application fee
-
For highly promising medicines of strategic importance, the agency can review complete sections of the file as they become ready, ahead of a formal conditional approval application. The agency decides on a rolling submission request within 10 working days. Medicines for unmet medical needs heading for conditional approval, decided case by case.
1. Ask for rolling submission; 2. Permission decision (10 days); 3. Submit complete sections as they are ready; 4. Rolling review of portions; 5. Formal conditional approval application.
Outcome: Early review of portions of the file, followed by a formal conditional approval 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 10 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 decision on permission to use rolling submission. | 10 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, 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.