Pharmacovigilance in Saudi Arabia According to SFDA
The pharmacovigilance landscape in Saudi Arabia is evolving rapidly as new medicines, biologics, and innovative therapies continue to enter the market.
According to the most recent Grand View Research outlook, the Saudi pharmacovigilance market was valued at $35.1 million in 2025. It is projected to reach $37.8 million in 2026 and approximately $56.6 million by 2033, representing a 5.9% CAGR between 2026 and 2033. To protect patient safety, Saudi Arabia has established a strong regulatory framework. At the center of this framework is the Saudi Food and Drug Authority (SFDA), which oversees drug safety monitoring and sets increasingly detailed local compliance requirements.
Pharmaceutical companies therefore need strong safety systems that comply with current SFDA Pharmacovigilance Requirements while remaining aligned with international pharmacovigilance standards. These systems must be capable of identifying, assessing, reporting, and managing drug safety concerns throughout the product lifecycle.
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Explore Saudi Arabia Pharmacovigilance Services →Understanding SFDA Pharmacovigilance Requirements for MAHs
The SFDA has established specific standards that Marketing Authorization Holders (MAHs) must follow to maintain an effective and compliant pharmacovigilance system.
- National Pharmacovigilance and Drug Safety Centre: Founded in 2009, the national centre is responsible for drug safety activities, including coordinating adverse drug reaction reports, evaluating safety signals, monitoring regulatory compliance, and supporting safety-related communications.
- Participation in the WHO Programme for International Drug Monitoring: Saudi Arabia became a full member in 2009, supporting the international exchange of safety data through the WHO programme and the Uppsala Monitoring Centre.
- Post-Marketing Surveillance of Advanced Therapy Medicinal Products (ATMPs): In April 2026, SFDA released dedicated GVP guidance for ATMPs covering long-term safety and efficacy monitoring along with PV risk management. The guidance is scheduled to take effect on April 12, 2027, and is intended to be used alongside the core GVP modules.
Saudi GVP Version 4.0: What Changed for MAHs?
Saudi GVP Version 4.0, updated on August 19, 2025, is the current foundation for SFDA pharmacovigilance compliance.
For MAHs, important changes include:
- Clearer overall pharmacovigilance responsibilities
- Updated QPPV qualification requirements
- Additional national PSSF requirements for computerized systems and databases
- Revised Saudi-specific RMP requirements
- RMP expectations for initial marketing authorization applications
- A standard PSUR/PBRER submission schedule
- Updated MAH responsibilities for signal management
- Revised Direct Healthcare Professional Communication (DHPC) requirements
- Additional documentation requirements for risk-minimization materials.
These changes make local governance more explicit. MAHs should review their SOPs, PSSF, QPPV oversight, contracts, risk-management processes, and regulatory calendars against Version 4.0 rather than relying on earlier SFDA GVP Guidelines.
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Explore QPPV Services →Key Elements of an SFDA-Compliant Pharmacovigilance System
A well-structured approach is essential for MAHs to achieve and maintain SFDA compliance.
This includes adverse-event intake, case processing, literature monitoring, aggregate reporting, risk management, documented safety agreements, appropriate computerized systems, and properly trained personnel.
What Are the SFDA QPPV Requirements in Saudi Arabia?
MAHs must appoint a full-time local Qualified Person for Pharmacovigilance (QPPV) who resides in Saudi Arabia.
One local QPPV service is required for each pharmacovigilance system, and both the QPPV and deputy must be registered through the Saudi Vigilance System.
Under current Saudi QPPV Requirements, the QPPV must:
- Hold at least a bachelor’s degree in pharmacy or medicine
- Be licensed by the Saudi Commission for Health Specialties (SCFHS)
- Maintain appropriate pharmacovigilance and epidemiology training
- Have sufficient authority and access to oversee the local PV system.
Responsibilities include oversight of local ICSRs, literature review, signal management, PSUR/PBRERs, RMPs, PSMF/PSSF documentation, safety agreements, and SFDA inspections.
If the QPPV resigns, SFDA must be notified, and replacement information should generally be submitted within 90 days, while the deputy provides interim coverage.
Create a Master File for the Pharmacovigilance System
- Global PSMF: MAHs must maintain a Pharmacovigilance System Master File describing how their overall PV system is organized and operated.
- Local PSSF: Multinational applicants and MAHs must also maintain a national Pharmacovigilance Sub-System File describing how the PV system operates specifically within Saudi Arabia.
- Regulatory scrutiny: Both documents must remain current and inspection-ready. SFDA can request the PSMF, while the PSSF must remain available to the local QPPV.
PSMF vs PSSF in Saudi Arabia: What's the Difference?
Area | PSMF | PSSF |
Scope | Global or overall pharmacovigilance system | Saudi-specific pharmacovigilance sub-system |
Purpose | Documents governance, organization, processes, and quality systems | Explains how the global PV system operates locally |
Content | Global PV structure, responsibilities, and processes | Saudi responsibilities, safety activities, contracts, systems, and local data |
For multinational MAHs | Required | Required in addition to the PSMF |
The documents are therefore complementary, not interchangeable. Version 4.0 also strengthens expectations around computerized systems and databases within the national PSSF.
Timely Reporting of Adverse Drug Reactions or ADRs
Healthcare professionals and patients can report suspected ADRs to SFDA through approved reporting channels.
MAHs must maintain systems capable of receiving, validating, following up on, and submitting reportable cases within SFDA timelines.
Submission of Safety Reports for Individual Cases (ICSRs)
Current SFDA requirements state that MAHs should report serious ICSRs occurring both inside and outside Saudi Arabia to the National Pharmacovigilance Centre.
Non-serious ICSRs occurring in Saudi Arabia must also be reported.
Important SFDA ICSR Reporting timelines include:
Case type | SFDA reporting timeline |
Serious ICSRs | 15 days |
Non-serious unexpected Saudi ICSRs | 15 days |
Non-serious expected Saudi ICSRs | 90 days |
Product-quality cases | 1 day |
Lack-of-efficacy cases | 15 days |
This updates the earlier assumption that SFDA primarily requires local ICSRs. MAHs should ensure that their ICSR case-processing service procedures reflect current SFDA requirements for both Saudi cases and applicable serious cases reported outside the country.
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Explore ICSR Services →SFDA Pharmacovigilance Literature Monitoring Requirements
Literature surveillance is a defined MAH responsibility under SFDA Pharmacovigilance requirements.
MAHs are expected to:
- Systematically search widely used scientific databases such as Medline or Embase at least once a week
- Monitor relevant local scientific and medical journals in Saudi Arabia
- Review relevant abstracts and manuscripts
- Regularly screen company-managed digital media where reportable safety information may arise.
Any literature report that meets valid ICSR criteria should enter the case-management process early enough to meet the applicable reporting deadline.
Literature monitoring should therefore be supported by documented search strategies, SOPs, clearly assigned responsibilities, and appropriate quality controls.
Safety Data Exchange Agreement (SDEA) in Saudi Arabia
When a distributor, licensing partner, affiliate, Pharmacovigilance service provider in Saudi Arabia, or another third party shares pharmacovigilance responsibilities or safety information, those responsibilities should be clearly documented through an SDEA or equivalent pharmacovigilance agreement.
The agreement should clearly address areas such as:
- Ownership and transfer of safety cases
- Day-Zero Awareness
- Reporting and exchange timelines
- Case follow-up
- Reconciliation
- Literature responsibilities
- Safety-signal escalation
- Record retention
- Audit responsibilities.
SFDA expects PV contractual arrangements to remain detailed and current, while the MAH retains ultimate responsibility for pharmacovigilance compliance.
Where PV activities are outsourced, applicable SFDA authorization requirements for the third party must also be considered. The local QPPV should have visibility of relevant agreements and safety-data exchange processes.
Periodic safety reporting remains an important part of evaluating a medicinal product’s evolving benefit-risk profile.
SFDA recognizes the PSUR/PBRER framework and permits alignment with the EURD list where applicable.
What Are the SFDA PSUR/PBRER Requirements in Saudi Arabia?
Under Version 4.0, the standard schedule is generally:
- Every six months after authorization, including before the product is marketed
- Once marketed, every six months for the first two years based on the international birth date
- Annually for the following two years
- Every three years thereafter, unless another SFDA or acceptable EURD schedule applies.
The earlier statement that SFDA does not require PSURs for generic drugs needs additional context. Routine PSUR/PBRER submission may be waived for many generic medicinal products. However, the waiver is not absolute.
A first generic registered in Saudi Arabia follows the applicable reporting schedule, and SFDA may require a PSUR/PBRER because of a marketing-authorization condition, an identified safety concern, or another regulatory need.
Where SFDA requests a report without specifying a submission deadline, Version 4.0 provides for submission within 90 calendar days of the data lock point.
Risk Control
Risk Management Plans (RMPs) and Risk Minimization Measures (RMMs) remain central to proactive drug-safety management.
MAHs must ensure that risk-management documentation reflects current product knowledge as well as Saudi-specific regulatory requirements.
What Are the SFDA RMP and Risk Minimization Requirements?
For full initial marketing authorization applications, all applicable parts of an RMP should be submitted.
For other application types, including certain generic, hybrid, fixed combination, and biosimilar products, SFDA applies a proportional approach based on the product’s identified and potential risks and the need for post-authorization safety data.
Where a global or EU RMP is used, a Saudi-Specific Annex (SSA) is generally required to address local exposure, Saudi-specific safety concerns, local pharmacovigilance activities, and risk-minimization measures, unless the RMP itself has been specifically prepared for Saudi Arabia.
After authorization, an RMP may require updating when:
- SFDA requests an update;
- A significant change affects the product’s safety profile;
- Indications, dosage forms, routes of administration, or relevant manufacturing processes change; or
- Additional pharmacovigilance or risk-minimization activities are introduced or removed.
Additional RMMs should be introduced when routine measures alone are insufficient. Their effectiveness should also be assessed and documented.
- PV Audits and Inspections –SFDA inspection activity demonstrates why documented compliance remains critical. According to the National Pharmacovigilance Centre’s 2025 annual inspection data, SFDA conducted 26 pharmacovigilance inspections, including routine and for-cause inspections, resulting in 217 findings: 19 critical, 137 major, and 61 minor.
Leading areas of findings included:
- Management and reporting of ADRs;
- QPPV requirements;
- PSMF;
- Signal management; and
- Written pharmacovigilance procedures.
MAHs therefore need a strong Quality Management System (QMS), effective CAPA processes, current SOPs, complete documentation, and inspection-ready evidence covering both internal and outsourced PV activities.
Challenges in Meeting SFDA Pharmacovigilance Guidelines
- Low reporting levels: The low level of ADR reporting by the public, due to limited awareness of the pharmacovigilance system remains a major challenge.
- Problems with implementation: When it comes to implementing Saudi Arabia GVP practices, MAHs may face obstacles, like insufficient corrective and preventive action (CAPA) systems and issues with ICSR timelines and follow-up.
- Communication gaps: Inconsistencies in data management can result from inadequate internal and external communication between MAHs and local regulatory agencies.
- Human resources: Lack of workers in PV domain, who are suitably qualified and trained.
How to Build an SFDA-Compliant Pharmacovigilance System?
- Create a Local Pharmacovigilance System: Apply such a system that covers assigning a QPPV and ADR reporting protocols.
- Create and Maintain PSURs and RMPs: To track and reduce product risks, update safety reports and risk management plans on a regular basis.
- Integrate Pharmacogenomic Data: To find possible adverse drug reactions (ADEs) associated with biomarkers, including genetic data in safety assessments.
- Increase Public Involvement: Support pharmacovigilance initiatives by taking part in awareness campaigns and using reporting channels
- Regional Cooperation: To improve pharmacovigilance procedures, cooperate with regional centres and follow international guidelines.
What Are the Latest Drug Safety Monitoring by SFDA Updates in 2026?
- Pharmacogenomics and Pharmacovigilance: SFDA initiated a pharmacogenomics-pharmacovigilance project in 2023 to identify and evaluate pharmacogenomics-related safety signals and understand the role of genetic biomarkers in adverse drug events.
- AI in Regulatory Work: SFDA has publicly highlighted the integration of artificial intelligence into drug-regulatory activities to support drug safety and quality. This should be distinguished from specific PV automation requirements unless formally defined by SFDA.
- Real-World Evidence: SFDA issued its first RWD/RWE framework in April 2026, with implementation from July 20, 2026. It provides a regulatory framework for using real-world data and evidence relating to medicine effectiveness and safety.
- ATMP Pharmacovigilance: Dedicated ATMP GVP guidance was issued in 2026 and is scheduled for implementation in April 2027, giving MAHs time to prepare appropriate long-term follow-up and risk-management processes.
Conclusion
Pharmacovigilance is evolving rapidly in Saudi Arabia. Version 4.0 of the SFDA GVP Guidelines places greater emphasis on local accountability, QPPV oversight, PSSF quality, timely ICSR reporting, literature monitoring, aggregate reporting, risk management, and documented safety-data exchange.
For pharmaceutical companies, meeting SFDA Pharmacovigilance Requirements is more than a registration obligation. It requires an ongoing system of governance, evidence management, regulatory oversight, and patient-safety decision-making throughout the product lifecycle.
How DDReg Supports Pharmacovigilance in Saudi Arabia
At DDReg, we offer Pharmacovigilance solutions & regulatory affairs services, tailored for the Saudi Arabian Pharma market, as per SFDA guidelines.
With deep regulatory and pharmacovigilance expertise, DDReg supports manufacturers and Marketing Authorization Holders in building compliant safety systems, maintaining local documentation, managing regulatory obligations, and navigating evolving SFDA requirements to protect patient safety and support better outcomes.
Read more from DDReg experts here: Signal Detection in Low-Volume Markets: How Smart PV Teams Stay Ahead
Frequently Asked Questions (FAQs)
The PSMF describes the overall pharmacovigilance system, while the PSSF focuses specifically on how that system operates in Saudi Arabia. For multinational MAHs, the PSSF complements the global PSMF by documenting Saudi-specific responsibilities, processes, systems, contracts, and safety activities.
Under current SFDA Pharmacovigilance requirements, MAHs should systematically search widely used scientific databases such as Medline or Embase at least once a week. Relevant Saudi medical and scientific literature should also be monitored so that potential reportable safety information can be identified and processed within the required timelines.
Not every generic medicine follows the same routine submission requirement. While PSUR/PBRER submission may be waived for many generic products, the first generic registered in Saudi Arabia may follow the applicable reporting schedule, and SFDA can request a report when there is a safety concern, marketing-authorization condition, or other regulatory need.
When an MAH relies on a global or EU Risk Management Plan, a Saudi-Specific Annex (SSA) is generally required to address Saudi-specific safety concerns, local exposure, pharmacovigilance activities, and risk-minimization measures. An SSA is generally not required when the RMP itself has been prepared specifically for Saudi Arabia.
Saudi GVP Version 4.0 strengthens several areas of pharmacovigilance compliance, including MAH responsibilities, QPPV qualifications, national PSSF requirements, RMP expectations, PSUR/PBRER reporting, signal management, and risk-minimization documentation. MAHs should therefore review their local procedures and regulatory systems against Version 4.0 rather than relying on older GVP requirements.