January 02, 2026

Saudi Arabia has rapidly become one of the most regulated and safety-focused pharmaceutical markets in the Middle East. With the Saudi Food and Drug Authority (SFDA) strengthening its pharmacovigilance (PV) ecosystem and implementing advanced safety monitoring frameworks, Marketing Authorization Holders (MAHs) must now operate robust, compliant, and audit-ready safety systems to remain competitive.

The Saudi PV market is expanding dramatically and is expected to grow at more than 60% annually, driven by national healthcare modernization, increased biologics and ATMP launches, and strategic national goals under Vision 2030.

Strong PV capability is no longer optional, it is a regulatory, operational, and market access imperative.

Understanding SFDA Pharmacovigilance Requirements

The SFDA has established a comprehensive regulatory structure to ensure drug safety throughout the product's lifecycle.

1. National Pharmacovigilance and Drug Safety Centre (NPVDSC)

  • Leads national drug safety efforts
  • Manages ADR reporting and signal detection
  • conduct awareness campaigns across healthcare and public networks
  • Oversees compliance with national safety standards

2. WHO-UMC Membership

Saudi Arabia has been a member of the WHO Uppsala Monitoring Centre since 2009, allowing:

  • Access to global VigiBase insights
  • Faster identification of emerging safety concerns
  • Contribution to international drug safety literature

3. ATMP Post-Marketing Surveillance

SFDA mandates:

  • Enhanced monitoring for cell and gene therapies
  • Early signal detection for adverse events
  • Continuous evaluation of benefit-risk profiles for high-complexity products

Key Components of an SFDA-Compliant PV System

A compliant pharmacovigilance system in Saudi Arabia must be detailed, fully documented, and locally anchored.

1. Appointment of a Local QPPV

Requirements

  • Must be a Saudi national or full-time resident
  • Licensed healthcare professional (pharmacist or physician) by SCFHS
  • Demonstrated pharmacovigilance competence

Responsibilities

  • Lead PV operations in Saudi Arabia
  • Respond to SFDA queries and inspections
  • Validate ICSRs, PSURs, and signal reports
  • Maintain PSMF/PSSF compliance
  • Serve as primary point of contact with SFDA

A strong QPPV is central to maintaining audit readiness.

2. Pharmacovigilance System Master File (PSMF) & PSSF

Global PSMF

Documents on the global PV governance structure.

Saudi-Specific PSSF

  • Mandatory for all MAHs
  • Describes the PV system as implemented specifically for Saudi Arabia
  • Includes local SOPs, risk management processes, QPPV responsibilities, and local safety workflows

SFDA routinely inspects both documents and expects accuracy, currency, and complete traceability.

3. Adverse Drug Reaction (ADR) Reporting Requirements

ADR sources include:

  • Healthcare providers
  • Hospitals
  • Pharmacists
  • Patients and caregivers
  • Local distributors

Electronic Systems

  • SFDA’s SAERS portal
  • Integration with VigiBase
  • Email and paper-based forms (when permitted)

Saudi Arabia emphasizes local ICSRs, requiring:

  • All serious and non-serious ADRs originating within Saudi Arabia
  • Strict timelines and follow-up procedures

4. Individual Case Safety Reports (ICSRs)

Local ICSRs

  • Mandatory submission of all Saudi-origin cases
  • Must follow SFDA’s format, completeness checks, and timelines

Global ICSRs

  • Submitted as required by periodic guidelines
  • Rules can change; MAHs must monitor SFDA circulars

Submission Channels

  • SAERS online
  • Email
  • Local partner using SDEA-compliant communication

5. Aggregate Reporting (PSURs / PBRERs)

  • PSURs must be submitted as per SFDA’s schedule
  • Typically aligned with EU Reference Date (EURD)
  • Generics may be exempt
  • Format must align with SFDA/ICH standards

6. Risk Management Plans (RMPs) and RMMs

Submission Requirements

  • Mandatory for new registrations
  • Required for new safety signals, new indications, or special populations

Key Expectations

  • Evidence-based risk minimization
  • Updated RMPs as new safety data emerges
  • Implementation of SFDA-mandated RMMs

7. SFDA Audits and Inspections

SFDA inspections frequently highlight:

  • Weak QMS documentation
  • Gaps in PSMF/PSSF alignment
  • Inadequate QPPV oversight
  • Missing CAPA documentation
  • Poor communication between MAHs and distributors

MAHs must maintain:

  • SOP adherence
  • Vendor oversight
  • QPPV governance
  • Real-time safety documentation

Challenges in Achieving SFDA Pharmacovigilance Compliance

  • Low public ADR reporting awareness
  • Delays in follow-ups and ICSR submissions
  • Insufficient CAPA systems
  • Limited workforce with specialized PV training
  • Inconsistent internal communication workflows
  • Rapid regulatory updates requiring continuous monitoring

Building SFDA-Recognized Pharmacovigilance Systems

To achieve full compliance, organizations must create locally tailored systems:

Establish a Local PV System

  • SFDA-qualified QPPV
  • Local SOPs and ADR workflows

Maintain PSMF & PSSF

  • Updated, audit-ready documentation

Strengthening Signal Detection

  • Use RWE, RWD, and advanced analytics

Integrate Pharmacogenomics

  • Identify genetic-biomarker-driven ADEs

Improve Public Awareness

  • Encourage ADR reporting through campaigns

Adopt Regional Collaboration

  • Aligning with GCC updates and international GVP standards

Latest SFDA Updates in Safety Monitoring (2023–2025)

1. Pharmacogenomics–PV Integration

  • Assessment of biomarker-linked ADEs
  • Improved prediction of population-specific risks

2. AI-Enabled Safety Monitoring

  • Automated triage
  • AI narrative writing support
  • ML-based signal detection

3. Real-World Evidence (RWE) Adoption

  • RWE is now used in post-marketing evaluation
  • Supports signal validation and risk management decisions

Conclusion

Saudi Arabia is emerging as a global benchmark for advanced, safety-centric pharmacovigilance.
 The SFDA’s stringent requirements, combined with modern methods such as AI, pharmacogenomics, and RWE, are redefining drug safety across MENA.

For MAHs, SFDA compliance is more than a regulatory necessity it is a commitment to patient protection, operational excellence, and long-term market success.

How Maven Regulatory Solutions Supports SFDA Pharmacovigilance Compliance

Maven Regulatory Solutions provides end-to-end pharmacovigilance and regulatory support aligned with SFDA expectations.

Our Expertise Includes:

  • Comprehensive PV system setup for Saudi Arabia
  • Local QPPV support and governance
  • PSMF/PSSF preparation and maintenance
  • ICSR collection, processing, and reporting
  • PSUR/PBRER creation and submission
  • RMP development and RMM implementation
  • Safety signal monitoring using AI and RWE integration
  • SFDA inspection readiness and CAPA remediation
  • Distributor oversight and SDEA management

Maven ensures that your pharmacovigilance operations in Saudi Arabia are compliant, efficient, and always audit-ready.