Author: Motaded Limited Team | Last updated: June 2026 | Reading time: 10 minutes
Saudi Arabia's pharmaceutical market is the largest in the Middle East, with an annual size exceeding SAR 35 billion. But before any pharmaceutical product enters Saudi pharmacies or hospitals, it must be registered with the Saudi Food and Drug Authority (SFDA) via the electronic Saudi Drug Registration system — known as eSDR. This guide explains the registration mechanism in detail, the five drug categories, actual fees, and the pre-pricing system that determines the drug price before the registration application begins.
Key point before reading: drug registration differs entirely from establishment registration. Pharmaceutical factory or warehouse licensing fees are detailed on the SFDA platform page. This article focuses solely on registering the pharmaceutical product itself.
What is the eSDR System?
The SDR (Saudi Drug Registration) is the official electronic platform launched by SFDA to manage the complete lifecycle of every drug registered in the Kingdom. The "e" in eSDR refers to "electronic" after the system was upgraded to a fully online version managing: initial registration applications, pre-pricing, registration renewal every five years, post-registration file variations, pharmacovigilance, and safety certificates.
The practical difference for a pharmaceutical company: before the electronic system, registration transactions were paper-based and multi-step. Now everything passes through a unified portal, but it requires preparing a technical file in the international CTD format (Common Technical Document) approved by ICH, and strict compliance with Saudi regulations.
The total cost of registering a new drug is not the SFDA fee alone. It consists of two separate parts: the SFDA fee + the eSDR system fee. Both are exclusive of 15% VAT.
The Five Drug Categories and Registration Fees
SFDA classifies drugs into five main categories, which differ fundamentally in registration difficulty, review time, and fees:
Category | Description | SFDA Fee | eSDR Fee | Total |
New drugs | Chemical, biological, biosimilars, radioactive | 95,000 | 20,000 | 115,000 |
Generic drugs | Identical copies of original drugs whose patent expired | 40,000 | 8,000 | 48,000 |
Health & herbal products | Supplements, medicinal herbs, health products | 20,000 | 4,000 | 24,000 |
IV solutions | Intravenous solutions, parenteral nutrition | 15,000 | 3,000 | 18,000 |
Veterinary drugs | Drugs for livestock and poultry | 5,000 | 1,000 | 6,000 |
Figures above are for the basic registration of one drug only. Every additional strength, additional pack type, or additional pack size requires separate fees. For example, one additional strength for a new drug adds SAR 27,600. An additional pack size adds SAR 7,400. Fees in Saudi Riyals exclusive of VAT.
The Pre-Pricing System — A Unique SDR Feature
SFDA is among the few global authorities that allow a pharmaceutical company to know the final price of its drug before submitting the registration application. The financial benefit: if the expected price doesn't justify the registration investment (SAR 115,000 for a new drug), the company can halt the process early and avoid losing fees.
Pre-pricing request fee: SAR 20,000. Response typically within 60-90 business days. It contains SFDA's proposed final price based on: comparison of prices in reference countries (International Reference Pricing), production cost, prices in EU and US markets, and the therapeutic added value compared with already-registered drugs. If you reject the price, you can submit an objection for SAR 1,000 per product, or withdraw and lose the SAR 20,000.
Practical advantage for serious companies: requesting pre-pricing is a smart move even if you are confident about the market. The final price may be lower than expected due to competing drugs at discounted prices. Knowing this before spending on the full registration file protects the budget.
Step-by-Step Registration of a New Drug via eSDR
Step 1: Establish a Legal Entity in Saudi Arabia
Foreign companies wishing to register their drugs in Saudi Arabia have two paths: establish a Saudi legal entity at 100% foreign ownership through the Ministry of Investment (MISA) then obtain the Commercial Registration from the Saudi Business Center, or appoint a licensed Saudi agent to handle registration on their behalf. Most choose direct establishment to retain control over pricing and distribution.
Step 2: License the Pharmaceutical Establishment
Before registering any product, a pharmaceutical factory must be licensed (SAR 10,000 for 5 years) or a pharmaceutical warehouse (SAR 4,000 for 5 years). Importing companies use the "warehouse + scientific representative" model. The scientific office costs SAR 1,000 for its initial registration + SAR 1,000 annually for its certificate.
Step 3: Prepare the CTD Technical File
The technical file (Common Technical Document) consists of five modules:
Module 1: Administrative and regional information (application form, labels, patient leaflet, Certificate of Pharmaceutical Product CPP, GMP certificate from country of origin).
Module 2: Summaries (Quality Overall Summary, Clinical Report, Non-Clinical Report).
Module 3: Complete quality data (formulation, manufacturing method, chemical tests, stability, reference analysis).
Module 4: Non-clinical reports (animal studies, toxicology, pharmacokinetics).
Module 5: Clinical reports (human safety and efficacy studies, special populations, statistical reviews).
Step 4: GMP Inspection of the Manufacturing Facility
All pharmaceutical manufacturers registered with SFDA undergo periodic GMP (Good Manufacturing Practice) inspections. Fees vary by manufacturer location: SAR 33,000 for Saudi Arabia, SAR 121,000 for Europe and Turkey, SAR 161,000 for North and South America, and SAR 184,000 for Australia and New Zealand (the highest globally). Inspection renews every five years.
Step 5: Technical Review and Pricing
After complete file submission, SFDA experts begin technical review in five committees (Chemistry, Biological, Clinical, Non-Clinical, Quality). The committee may request clarifications or additional data. In parallel, the pricing committee begins its work to determine the final price.
Step 6: Registration Decision and Certificate
After review completion, the registration decision is issued valid for five years. The certificate (SAR 1,000 per separate certificate) includes: drug name, category, manufacturer, registrant company, final price, and approved indications.
Registration Renewal After 5 Years
SFDA registration is not permanent. Every registered drug needs renewal every five years, with fees lower than initial registration but not symbolic:
| Renewal Type | SFDA Fee | eSDR Fee | Total |
| New drug renewal | 30,000 | 3,000 | 33,000 |
| Generic drug renewal | 10,000 | 1,000 | 11,000 |
| Health/herbal renewal | 8,000 | 800 | 8,800 |
| Veterinary drug renewal | 1,000 | 100 | 1,100 |
| IV solution renewal | 5,000 | 500 | 5,500 |
Renewal must be submitted 6 months before the expiry date. If the deadline passes, the drug loses its registration and is immediately banned from sale. To re-register after loss, full initial registration fees are paid again. This is a common mistake that occasionally costs pharmaceutical companies hundreds of thousands of riyals.
Post-Registration File Variations
After drug registration, any modification requires SFDA's prior approval. The variation fee is fixed: SAR 4,000 (SAR 3,000 SFDA fee + SAR 1,000 eSDR fee) per change application. Common changes include:
• Change of manufacturer or manufacturing location
• Change of label or patient leaflet
• Modification in formulation or excipients
• Change of brand name
• Change of pack size or shape
• Update of indications or precautions based on new pharmacovigilance data
Some changes (such as manufacturer change) require additional GMP inspection, increasing actual cost. Simple administrative changes (such as office address change) do not require fees.
Clinical Trials in Saudi Arabia
Companies wanting to conduct clinical trials on humans in Saudi Arabia (Phase 1, 2, 3, or 4) need a separate license from SFDA. The fee is SAR 15,000 per study. Approval requirements include: study protocol, ethics committee approval from participating hospitals, patient safety plan, and mechanism for reporting serious adverse events (SAE) within 24 hours of occurrence.
Foreign companies conducting trials need a licensed clinical study follow-up center in Saudi Arabia (SAR 5,000 for the license for 5 years), or a partnership with a licensed local center. This path is attractive for companies because the Saudi patient base is genetically diverse and cooperative, and the major hospital infrastructure is advanced.
Post-Registration Obligations — Pharmacovigilance
Drug registration is not the end of the path. SFDA imposes ongoing obligations on the registrant company throughout the drug's marketing period:
• Reporting any serious adverse event detected in Saudi Arabia within 15 days (24 hours for fatal or life-threatening events).
• Submitting Periodic Safety Update Report (PSUR / PBRER) every 6 months in the first two years of registration, then annually, then every 3 years.
• Maintaining production, distribution, and recall records for at least 10 years.
• Responding to any SFDA request to withdraw a batch from the market within 48 hours.
• Updating the technical file when any new safety data is issued internationally (for example, if FDA or EMA issues a warning).
Breach of any of these obligations may lead to registration suspension or permanent cancellation. Major global companies have lost important drug registrations in Saudi Arabia due to delayed PSUR reports.
Why Are Drug Registration Applications Rejected?
More than 40% of registration applications face clarification requests or partial rejection in the first review. The most recurring reasons:
• Certificate of Pharmaceutical Product (CPP) from country of origin not attested by the Saudi embassy or with apostille stamp.
• Stability studies insufficient for Climate Zone IVb to which Saudi Arabia belongs — requires 12-month trials at 40°C and 75% humidity as minimum.
• Inaccurate translation of patient leaflet into Arabic, or confusion between sensitive technical terms.
• Clinical data based on studies in populations unrepresentative of the region (such as studies on Americans only for a drug targeting the Middle East).
• Quality file (Module 3 of CTD) missing certain tests such as impurities or dissolution.
• Claims in patient leaflet unsupported by formal clinical studies.
How Motaded Limited Helps
Drug registration is the most complex regulatory sector in SFDA, and the most costly when errors occur. We have helped 281 establishments comply with SFDA, and our specialized pharmaceutical sector team handles: legal entity establishment, factory or warehouse licensing, complete CTD file preparation per SFDA requirements, coordination with international GMP certificates, managing pre-pricing requests, follow-up of technical review, drug certificate issuance, and management of post-registration obligations (PSUR, pharmacovigilance). Discover the complete package on the SFDA platform page or book a meeting with our pharmaceutical sector expert to discuss your specific product.
Related Articles
If your activity also covers other SFDA sectors, explore our specialized guides: Medical Device Registration (MDMA), Cosmetics Listing (eCosma), Food Establishment Licensing. For imported shipments, see the FASAH platform page.
Conclusion
Drug registration in Saudi Arabia via the SDR system is a costly and complex process (SAR 115,000 for a new drug + GMP inspection up to SAR 184,000 + ongoing pharmacovigilance obligations), but it is a justified investment to access the largest pharmaceutical market in the region. The five drug categories have fundamentally different requirements, and the pre-pricing system is a unique feature to exploit. Common errors in the CTD file cost significant time and money. Motaded Limited provides an integrated drug registration service with a specialized team. Book a free meeting now to evaluate your product and determine the total cost and expected timeline.
What is the actual timeline to register a new drug from scratch at SFDA?
In the ideal case with a complete file, 12-18 months for a new drug. For a generic 6-12 months. For a health/herbal product 4-8 months. These periods include: file preparation (3-6 months), technical review (6-9 months), pricing (2-3 months), final decision issuance (1 month). Motaded shortens the period by 20-30% thanks to preparing a clean file that avoids repeated clarification requests.
Must the drug be registered in Europe or the United States before Saudi Arabia?
No, but having prior registration from a reference authority (FDA, EMA, MHRA, Health Canada, PMDA) accelerates review and increases acceptance chances. SFDA recognizes the reports of reference authorities and relies on them heavily in evaluating safety and efficacy. Drugs registered with a reference authority benefit from a shortened review pathway.
What is the difference between a generic drug and a biosimilar?
A generic drug is a chemically identical copy of an original drug whose patent has expired (such as paracetamol). Its registration fee is SAR 48,000. A biosimilar is a copy of a complex biological drug (such as insulin or antibodies), manufactured from living cells and impossible to be 100% identical to the original. Its registration fee is treated as a "new drug" at SAR 115,000 because it needs clinical studies to prove biosimilarity.
Is pre-pricing mandatory or can it be skipped?
Not mandatory, but a smart investment of SAR 20,000 that protects you from spending SAR 115,000 on a registration that may be economically unviable. For drugs competing in a crowded market, pricing may be much lower than expectations. For unique drugs without competition, pricing may be better than expectations. Both scenarios warrant knowing before spending.
What happens if a drug registration application is rejected?
SFDA sends the rejection decision with its specific reasons. The company has the right to re-submit after addressing the reasons, but previously paid fees are not refunded. A formal appeal can also be submitted if the company considers the rejection technically unjustified. To avoid this, the solution is to prepare a clean file from the start with review by a regulatory consultant experienced in SFDA.
Can a drug be registered for a single use in Saudi Arabia (Orphan Drug)?
Yes, SFDA has a special pathway for orphan drugs designated for rare diseases. Fees are the same as a new drug (SAR 115,000) but the review is faster and more flexible, and the required clinical evidence is less due to the difficulty of conducting studies on a large number of patients. This pathway is attractive for companies specialized in rare disease treatments and pediatric genetic diseases.