Saudi Arabia's pharmaceutical market is valued at approximately USD 10.86 billion in 2025, with projected growth at a CAGR of 6.18% through 2032.[1] For pharmaceutical companies seeking market access, SFDA drug registration is the critical gateway—and understanding the process can mean the difference between timely market entry and costly delays.
This comprehensive guide covers the complete SFDA registration process, from initial application through post-approval requirements, helping regulatory affairs professionals navigate Saudi Arabia's pharmaceutical approval system efficiently.
The Saudi Food and Drug Authority (SFDA) is the regulatory body responsible for ensuring the safety, efficacy, and quality of pharmaceutical products in Saudi Arabia. Established by Royal Decree No. (M/6) dated 25/1/1428 H (13/02/2007), the SFDA oversees the manufacture, import, export, distribution, promotion, and advertising of medicinal products.[2]
Key milestones:
The SFDA processes registrations for four main categories of medicinal products:[5]
| Category | Description | Documentation Requirements |
|---|---|---|
| New Drug | Novel chemical entities, including biosimilars | Full 5-module CTD dossier |
| New Chemical Entity | First-in-class compounds | Complete clinical and non-clinical data |
| Generic Drugs | Bioequivalent versions of approved drugs | Abbreviated dossier with BE studies |
| Biological Drugs | Biopharmaceuticals and biosimilars | Full quality, non-clinical, and clinical modules |
Before submitting a drug registration application, pharmaceutical companies must fulfill several prerequisites.
All manufacturers—domestic and international—must comply with SFDA's GMP Guidelines, which are based on WHO and PIC/S standards.[4]
GMP inspection process:
Common GMP deficiencies (2018-2021 SFDA data):[4]
The SFDA requires applications in the electronic Common Technical Document (eCTD) format, aligning with ICH standards.[6]
| Module | Content | Requirements |
|---|---|---|
| Module 1 | Administrative Information | Application forms, cover letters, CPP, authorization letters, patent declaration |
| Module 2 | Summaries | Quality, non-clinical, and clinical overviews |
| Module 3 | Quality (CMC) | Drug substance and drug product specifications, stability data |
| Module 4 | Non-Clinical | Pharmacology and toxicology studies |
| Module 5 | Clinical | Clinical study reports, efficacy and safety data |
Foreign pharmaceutical companies must appoint a Saudi Authorized Representative (SAR) for regulatory submissions.[3]
Local agent requirements:
Before submitting applications, companies must register with the Drug Establishments National Registry (DENR) to obtain login credentials for SFDA's electronic systems.[5]
Electronic systems used:
SFDA allows companies to request pre-submission meetings and pre-pricing assessments.
Pre-pricing service:[10]
Submit the complete Marketing Authorization Application (MAA) through the eSDR system.[5]
Submission requirements:
SFDA conducts initial completeness and technical verification.[5]
What's checked:
Timeline: Validation typically completed within 30 days
The comprehensive evaluation phase includes multiple review tracks:[3]
Review components:
Common areas generating Requests for Information (RFIs):[6]
Timeline: 180-365 days for standard review
Conducted in parallel with scientific assessment:[4]
All pharmaceutical products must receive pricing approval before marketing.[10]
Reference pricing guidelines:[10]
| Generic Sequence | Maximum Price (vs. Innovator) |
|---|---|
| First generic | 70% |
| Second generic | 65% |
| Third and subsequent | 60% |
| Biosimilar Sequence | Maximum Price (vs. Biological) |
|---|---|
| First biosimilar | 75% |
| Second biosimilar | 65% |
| Third and subsequent | 55% |
The SFDA Registration Committee reviews all evaluation reports and issues approval or rejection.[3]
Approval outcomes:
SFDA offers several accelerated routes for qualifying products.[12]
Introduced in 2014, priority review offers a 40% reduction in standard timelines.
Eligibility criteria:
Timeline: 93 working days for human generic drugs under priority review[12]
Available for products approved by both USFDA and EMA—the fastest pathway.[5]
Available for products approved by either USFDA or EMA.[5]
| Phase | Timeline |
|---|---|
| Validation | ~30 days |
| Scientific Assessment | 180-365 days |
| GMP Inspection | Concurrent with assessment |
| Pricing Review | 60-90 days |
| Registration Committee | Variable |
| Total (Standard) | 12-18 months |
| Total (Priority Review) | 6-9 months |
Based on available information, key SFDA fees include:[8]
| Service | Fee (SAR) |
|---|---|
| Drug variation application (per SKU) | 15,000 |
| Certificate issuance | 1,000 |
| Manufacturer certificate | 10,000 |
| Scientific office certificate (annual) | 1,000 |
| Authorized representative license (annual) | 2,600 |
| Pre-pricing assessment | 20,000 |
| New drug renewal (SFDA fee) | 30,000 |
| Generic drug renewal (SFDA fee) | 10,000 |
SFDA established the National Pharmacovigilance and Drug Safety Center (Saudi Vigilance) in 2009.[14]
Qualified Person for Pharmacovigilance (QPPV):[14]
Post-approval changes require variation submissions classified by impact:[16]
| Type | Description | Process | Timeline |
|---|---|---|---|
| Type IA | Minor, no prior approval needed | "Do and Tell" | Submit within 14 days |
| Type IB | Minor, notification required | "Tell, Wait and Do" | 120 days before implementation |
| Type II | Major, prior approval required | Full assessment | 145 working days target |
Drug registration certificates are valid for 5 years.[16]
Renewal requirements:
Expanding into other GCC markets? Explore our related compliance guides:
Managing SFDA regulatory submissions involves processing thousands of pages of documentation across multiple CTD modules. ByteBeam's document automation platform helps pharmaceutical regulatory teams streamline this process.
Key capabilities:
ByteBeam enables regulatory affairs teams to reduce document preparation time by up to 60%, allowing faster response to RFIs and accelerating time to market.
SFDA drug registration in Saudi Arabia requires thorough preparation, proper documentation, and understanding of the regulatory landscape. Key takeaways:
Last updated: January 2026. Regulations may change. Always verify current requirements with SFDA official sources at sfda.gov.sa.