Pharmacovigilance in the Saudi Arabia is growing as fast as ever, with new advancements entering rapidly into the market. According to Grandview Research, the Saudi Arabian PV market is expected to grow at an annual rate of 60.9 percent & generate $49.0 million revenues by 2030.
To ensure patient safety, a strong regulatory framework has been implemented. At the center of this is the Saudi Food and Drug Authority (SFDA), known for its robust drug safety monitoring and stringent regulations in Saudi Arabia and across the Middle East. Pharmaceutical companies, thus need to develop robust safety systems that adhere to SFDA guidelines. To turn Pharmacovigilance in Middle East(MENA Regions) into a global practice, these systems must strictly monitor, handle and react to drug safety issues in real time.
Understanding SFDA Pharmacovigilance Requirements
The SFDA has set certain specific requirements that MAHs must follow, to construct a compliant safety system.
- National Pharmacovigilance and Drug Safety Centre: Founded in 2009, this SFDA-affiliated centre manages drug safety initiatives such as tracking adverse events and ensuring safety rules are followed. To support the national pharmacovigilance infrastructure, it involves reporting adverse drug reactions (ADRs), launching awareness campaigns and reacting to safety signals.
- Membership in the WHO-UMC: Saudi Arabia joined the Uppsala Monitoring Centre in 2009, to gain access in global medical safety data and contribute to local research.
- Post-Marketing Surveillance of Advanced Therapies Medicinal Products (ATMPs): This program seeks to identify and assess possible safety indicators associated with ATMPs guaranteeing current safety data on labels and prompt identification of safety issues. Creating a list of safe pharmaceuticals and thorough drug safety assessments are its key activities.
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Key Elements of an SFDA-Compliant Pharmacovigilance System
A thorough approach to system building is necessary for MAHs to attain and maintain SFDA accuracy, that include everything- from gathering adverse event reports to using innovative software tools and educating teams on how to handle safety data. Following are some critical components.
Appoint a Qualified Person for Pharmacovigilance in Saudi Arabia
- Nationality: Marketing Authorization Holders (MAHs) must appoint a full-time, locally based Qualified Person for Pharmacovigilance (QPPV) in Saudi Arabia.
- Professional background: The QPPV must be licensed by the Saudi Commission for Health Specialties (SCFHS) to hold a degree in medicine or pharmacy and have the necessary education & training.
- Responsibilities: Manage SFDA inspections, evaluate safety data reports or exchange agreements, approve aggregate and signal reports and supervise local PV operations. The local QPPV thus serves as the SFDA’s main point of contact
Create a Master File for Pharmacovigilance System (PSMF)
- Global PSMF: MAHs are required by GVP to keep a Pharmacovigilance System Master File (PSMF) to record the functionality of their global PV system.
- Local PSSF: The Pharmacovigilance Sub-System File (PSSF) is a Saudi-specific requirement. International MAHs must create and maintain this file to describe their PV system for Saudi Arabia.
- Regulatory scrutiny: Throughout the drug registration and inspection procedures the SFDA will keep a careful eye on the PSMF and PSSFs integrity.
Timely Reporting of Adverse Drug Reactions or ADRs
- Sources: Health care providers (HCPs) and patients can submit spontaneous ADR reports to the SFDA via paper and online forms.
- Electronic systems: To gather store and examine reports the SFDA makes use of sophisticated electronic database systems. This includes using its own systems and having access to the WHOs VigiBase for signal detection.
- Local reports: To streamline the reporting process, the SFDA focuses on submitting local (Saudi) serious and non-serious Individual Case Safety Reports (ICSRs) over global ICSRs, since 2019.
Submission of Safety reports for Individual Cases (ICSRs)
- Local ICSRs: MAHs are required to provide the SFDA with all local (Saudi) ICSRs for significant and non-serious adverse drug reactions (ADRs).
- Global ICSRs: Although the SFDA previously blocked the receipt of global ICSRs for a short time businesses are still required to abide by the rules as they stand which could change.
- Reporting methods: The SFDA takes reports by email paper forms and online (through the Saudi Adverse Event Reporting System SAERS). A Safety Data Exchange Agreement (SDEA) is necessary for an MAH’s local distributor.
Aggregate Reporting
- Periodic Safety Update Reports (PSURs): To assess the benefit-risk balance of their products, MAHs are required to submit PSURs to the SFDA on a regular basis. The SFDA provides a schedule for PSURs which typically corresponds with the EU Reference Date (EURD) list.
- Generic drug distinction: In contrast to the Arab Good Pharmacovigilance Practices or (GVP) guidelines, the SFDA does not require PSURs for generic drugs.
- Report format: Formats and instructions must be in accordance with SFDA-approved guidelines.
Risk Control
- Risk Management Plans (RMPs): For new registrations or for products with new safety concerns or other major changes, the SFDA mandates that businesses must submit RMPs.
- Risk Minimization Measures (RMMs): The SFDA has put strict requirements for companies to submit and prove the efficacy of their RMMs. As new safety data becomes available, MAHs must update their RMPs and apply any SFDA-risk minimization measures, if necessary.
- Requirements for submission: RMPs must be included with new applications for marketing authorization of new indications or new age groups. For products that are already registered, the SFDA may request RMPs.
Audits and Inspections
- Increased scrutiny of MAHs: ADR management in SFDA include PSMF and the QPPV Major findings have increased especially among international MAHs, according to a 2025 mid-year report.
- Focus on compliance: MAHs need to make sure that every part of their PV system is recorded and complies with local GVP regulations to be ready for SFDA inspections.
- Strong quality management system (QMS): Ensures that all pharmacovigilance procedures and results fulfil predetermined quality standards. An important finding is non-compliance in this area.
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.
- Gaps in communication: 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 SFDA-Recognized Pharmacovigilance Systems?
- 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.
Recent Updates in Drug Safety Monitoring by SFDA
- Project on Pharmacogenomics and Pharmacovigilance: The SFDA started a project in 2023, to incorporate pharmacogenomic information into pharmacovigilance processes. This project assesses & detects pharmacogenomics-related safety signals, to evaluate how genetic biomarkers affect drug-induced adverse drug events (ADEs).
- AI-Enabled Safety Monitoring: Automation in tasks like signal detection, narrative write up and case triaging, for better patient outcomes.
- Adoption of Real-World Evidence (RWE): For better post-marketing analysis and deeper safety insights, RWE and real-world data (RWD) are now used in drug monitoring.
Conclusion
Pharmacovigilance is changing dramatically in the Middle East especially in Saudi Arabia. With the extensive regulatory framework and cutting-edge initiatives of the SFDA the region is well-positioned to establish new standards for drug safety. Pharmaceutical consulting firms thus view adherence to SFDA standards as a commitment to patient safety and wellbeing, rather than a legal necessity.
How can DDReg help you?
At DDReg, we offer Pharmacovigilance solutions & regulatory affairs services, tailored for the Saudi Arabian Pharma market, as per SFDA guidelines. With our deep expertise in pharma solutions & expert PV knowledge, DDReg thus empowers manufacturers & market authorizers to navigate through the complex Middle East market, particularly in South Arabia to ensure the safety & efficacy of their drug, for better patient outcomes.
Read more from DDReg experts here: Signal Detection in Low-Volume Markets: How Smart PV Teams Stay Ahead