What is SFDA? Saudi Arabia’s Regulatory Authority for Medicinal Products

What is SFDA? Saudi Arabia’s Regulatory Authority for Medicinal Products

The Saudi Food and Drug Authority (SFDA) is the Kingdom of Saudi Arabia’s primary Regulatory health authority overseeing the safety, efficacy, and quality of medicinal products. For global pharmaceutical manufacturers, compliance with SFDA requirements is a prerequisite for market authorization and sustained access to one of the Middle East’s most lucrative healthcare markets.

SFDA’s Technical Role in Medicinal Product Regulation

Drug Registration & Marketing Authorization (MA)

• Scope: New Chemical Entities (NCEs), New Biological Entities (NBEs), biosimilars, generics, and traditional medicines
• Submission Format: Common Technical Document (CTD/eCTD) aligned with ICH standards
• Evaluation: Clinical, non-clinical, and Chemistry, Manufacturing, and Controls (CMC) modules undergo a detailed review
• Outcome: Issuance of Marketing Authorization allowing commercialization in the Kingdom

Good Manufacturing Practice (GMP) Compliance

• Inspection: Local and foreign manufacturing sites are subject to SFDA GMP inspections
• Standard Alignment: SFDA recognizes PIC/S GMP guidelines and requires documentary evidence of compliance
• Objective: Guarantee consistent quality across imported and locally manufactured products

Pharmacovigilance (PV) & Post-Market Surveillance

• Requirements: MAHs must establish a local PV system in compliance with Good Pharmacovigilance Practices (GVP-KSA)
• Adverse Drug Reaction (ADR) Reporting: Mandatory submission of Individual Case Safety Reports (ICSRs) and Periodic Safety Update Reports (PSURs)
• Risk Management: Risk minimization and corrective actions required in case of emerging safety signals

Labeling & Packaging Controls

• Mandatory Arabic Labeling: All packaging, inserts, and labeling must be in Arabic (with English permitted in parallel)
• Regulatory Scope: Includes inner and outer packaging, storage instructions, and patient information leaflets
• Variation Handling: Label changes require prior approval via variation applications to SFDA

Lifecycle Management

• Variations: Covers manufacturing site changes, process modifications, labeling updates, and new indications
• Renewals: Marketing authorizations are valid for 5 years and require renewal
• Withdrawals & Suspensions: SFDA reserves the right to suspend or revoke approval if compliance lapses

Key Technical Requirements for Foreign Companies

• Local Representation: Mandatory appointment of a Saudi-based local agent/sponsor to act as liaison with SFDA
• Dossier Standards: Alignment with CTD/eCTD modules (M1–M5) for drug registration
• Clinical Data Expectations: NCEs require full clinical evidence; generics must submit bioequivalence studies per SFDA standards
• Batch Release & Testing: Imported products may be subject to local quality control testing before release
• Electronic Submissions: Transition to eCTD format is strongly encouraged for efficiency and compliance
• Why SFDA is Critical for Medicinal Products

The SFDA ensures that medicinal products in Saudi Arabia are:

• Safe – minimizing risk through stringent PV and ADR reporting
• Effective – granting approvals only after robust benefit-risk evaluation
• High-quality – requiring GMP certification and lifecycle compliance

For pharmaceutical sponsors, early integration of SFDA requirements into Regulatory strategy is vital for accelerated approvals and sustainable compliance.

Conclusion

The SFDA is the backbone of Saudi Arabia’s medicinal product Regulatory ecosystem. From drug registration and GMP compliance to pharmacovigilance and lifecycle management, SFDA ensures medicines meet the highest standards.

For pharmaceutical companies, navigating SFDA regulations demands expertise and precision. Partner with Freyr’s Regulatory specialists to streamline your submissions, ensure compliance, and accelerate access to the Saudi market. Contact us today to get started.