Expert Guidance for Drug Product Registration in Saudi Arabia
Saudi Arabia represents one of the most advanced and rapidly expanding pharmaceutical markets in the GCC. However, successful entry demands a deep understanding of the regulatory environment governed by the Saudi Food and Drug Authority (SFDA) and a strategic approach to pharmaceutical product registration in Saudi Arabia.
At DDReg, we specialize in Saudi Arabia drug product registration, supporting global pharmaceutical manufacturers and local distributors with end-to-end regulatory guidance, dossier preparation, and lifecycle management. Our expertise ensures seamless compliance with SFDA’s evolving requirements for pharmaceutical drug registration in KSA.
SFDA Drug Registration Process in Saudi Arabia
The SFDA (Saudi Food and Drug Authority) oversees all aspects of drug regulatory services in Saudi Arabia, including the manufacturing, import, export, distribution, promotion, and advertising of medicinal products. All pharmaceutical products marketed in Saudi Arabia must be registered with the SFDA before commercialization.
Medicinal Product Classification in Saudi Arabia
Medicinal products in KSA are classified under the following categories:
- New Drug
- New Chemical Entity
- Generic Drug
- Biological Drug
Step-by-Step SFDA Drug Products Registration Pathway
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1
Online Registration (DENR)
Applicant registers to obtain login credentials and access electronic services.
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2
MAA Submission via SDR
Submit eCTD dossier, CPP and required hard copies through SDR portal.
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3
Validation
SFDA verifies completeness of the submission.
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4
Assessment & Inspection
Technical evaluation, GMP inspection, and sample testing.
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5
Pricing Review
Review performed per SFDA pricing rules.
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6
Product Licensing
Marketing Authorization granted after committee approval.
| Pathway Type | Applicable When | Typical Duration |
|---|---|---|
| Standard Review | Regular new or generic drug submissions | 12–18 months |
| Abridged Review | Product approved by either USFDA or EMA | 6–9 months |
| Verification Pathway | Product approved by both USFDA and EMA | 4–6 months |
| Fast-Track Review | Life-saving or public-health priority drugs | Case-specific (3–6 months) |
Local Representation and GMP Compliance
Foreign manufacturers must appoint a local authorized representative in Saudi Arabia to act as the Marketing Authorization Holder (MAH). The MAH manages:
- Regulatory communication with SFDA
- Import licensing and shipment authorization
- Product variation, renewal, and post-approval submissions
Manufacturing facilities must comply with Good Manufacturing Practices (GMP) recognized by SFDA.
GMP inspection may be waived if the site is approved by the Gulf Central Committee for Drug Registration (GCC-DR), USFDA, or EMA, a process DDReg expertly facilitates through GMP dossier alignment and inspection readiness support.
Product Maintenance and Post-Approval Compliance
| Application Type | Validity / Requirement |
|---|---|
| Marketing Authorization Certificate | Valid for 5 years from approval date |
| Renewal Application | To be filed 6 months before expiry |
| Post-Approval Variations | To be submitted with justification and supporting documentation |
Our Regulatory Services for Pharmaceutical Product Registration in Saudi Arabia
We provide comprehensive SFDA drug registration services that cover the full regulatory lifecycle:
- End-to-End Pharmaceutical Product Registration in Saudi Arabia
- Medicinal Product Classification & Pre-submission Strategy
- Regulatory Affairs Consulting for Pharmaceutical Products in KSA
- Gap Analysis and Dossier Review as per SFDA requirements
- CTD/eCTD Dossier Preparation and Electronic Submission
- Authorized Local Agent Support for Foreign Manufacturers
- GMP Certification and Audit Readiness Assistance
- Pricing Strategy Support aligned with SFDA’s pricing framework
- Regulatory Query Management until approval
- Lifecycle Management: Renewals, Variations & Post-Approval Support
- Regulatory Intelligence and SFDA Updates Monitoring
Why Partner with DDReg for Drug Registration in Saudi Arabia
- In-depth expertise in SFDA, GCC-DR, and ICH guidelines ensuring scientifically sound submissions.
- We blend international regulatory experience with on-ground Saudi market knowledge for seamless execution.
- Through optimized reliance and abridged pathways, we help accelerate your SFDA approval timelines.
- From dossier development to post-marketing surveillance, DDReg ensures ongoing compliance.
Related Regulatory Services
- GCC Centralized Registration Support
- Pharmacovigilance and Safety Reporting Services in Saudi Arabia
- Regulatory Labeling and Artwork Compliance
- Market Access and Regulatory Intelligence for Middle East Markets