Saudi Arabia · Saudi Food and Drug Authority · New drugs
Review target
280 working days
official guidance
Legal time limit
-
Not published
Steps
10
19 requirements
Application fee
SAR 95,000
Fee decision 64/32 (2011)
The SFDA must register a medicine before it is marketed in Saudi Arabia. In the regular pathway the agency validates the file, evaluates quality, safety and efficacy, checks the manufacturing site, sets the price, and its Registration Committee decides. Targets are counted in working days and pause while the agency waits for the applicant. New chemical entities and biological products, including vaccines, blood derivatives, recombinant proteins and cell or gene therapies, when no faster route is used.
The official review target is 280 working days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The evaluation of a new drug or biological application is SAR 95,000 for Fee decision 64/32 (2011).
1. Apply online and pay the fee; 2. Technical validation; 3. Business validation (10 days); 4. Complete the file (clock stopped); 5. Evaluation and inspection (245 days); 6. Answer questions (clock stopped); 7. Laboratory testing; 8. Pricing (20 days); 9. Registration Committee decision (15 days); 10. Marketing authorization issued.
Outcome: Marketing authorization issued through the SDR system. It is renewed every five years. Valid for 5 years.
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 315 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. Business validation target. It is not counted in the total review target. | 10 working days |
| Longest clock stopofficial guidance. Time the applicant has to answer one wave of questions. At most four waves are allowed. | 60 working days |
| Review targetofficial guidance. Official target for products already registered with a stringent regulatory authority (US FDA, EMA, MHRA, Swissmedic, Health Canada, TGA or PMDA). The target is 405 working days for other products. Business validation and applicant time are not counted. Actual times can differ. | 280 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Evaluation of a new drug or biological applicationApplication · Fee decision 64/32 (2011) | SAR 95,000 |
| License renewal, new drug or biologicalRenewal · Fee decision 64/32 (2011) | SAR 30,000 |
Other routes in Saudi Arabia: 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), Research and Investigational Drugs (RAID) designation, Medical Device Marketing Authorization (MDMA). 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 (45 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.