Pharmacovigilance services in Saudi Arabia

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Saudi Arabia, exploring DDReg’s pharmacovigilance services in Saudi Arabia is critical to ensure drug safety and regulatory compliance. From adverse drug reaction reporting to compliance with SFDA pharmacovigilance regulations, the right PV partner shapes everything, including signal detection, risk management planning, safety reporting, and successful market authorization.

Expert Pharmacovigilance Services for the Saudi Arabia Market

The Saudi Food and Drug Authority (SFDA), under the Ministry of Health, is the national authority responsible for the safe use of food, drugs, and biological and chemical substances. The SFDA's National Pharmacovigilance Centre (NPC) focuses on monitoring the safety profiles of medications, ensuring a positive benefit-risk balance. Since its establishment, the NPC has overseen pharmacovigilance services such as adverse drug reactions (ADRs) reporting, risk management plans (RMPs), Periodic Safety Update Reports (PSURs),individual case safety reports (ICSRs), signal detection, data mining, and risk communication. Adverse reactions can be reported by physicians, pharmaceutical companies, and the general public through various channels, including online platforms, email, paper forms, fax, mail, or phone calls.

Saudi Arabia mandates that international Marketing Authorization Holders (MAHs) establish and maintain local pharmacovigilance services, documented in a file called the “Pharmacovigilance Sub-System File (PSSF).” Additionally, MAHs are required to document ADR information in the company’s global Pharmacovigilance System Master File (PSMF). A dedicated Qualified Person Responsible for Pharmacovigilance (QPPV ), residing in the country, must oversee these activities. Despite having an advanced pharmacovigilance system, challenges such as underreporting from the public and lack of awareness persist.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case processing through E2B(R3) compliant databases integrated with drug dictionaries (WHO DD) and MedDRA
  • Quality checks and medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR monitoring and tracking sheets
  • Reconciliation processes with customers
• + Risk Management Plan (RMP)
  • Drafting, reviewing, and maintaining RMPs and REMS
  • Preparing customized procedures to classify safety risks and deliver tailored risk management strategies
  • Assessment of potential risks and missing information
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS)
  • Effectively conveying risks through labeling documents such as Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PILs)
• + Aggregate Reports
  • Periodic Safety Update Reports (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Identification of new safety signals and changes in risks concerning a pharmaceutical product from ICSR databases, literature, and regulatory agency website monitoring
  • Utilization of in-house tools and databases for signal detection and tracking
  • Review of safety signals and recommendations by Pharmacovigilance Risk Assessment Committees (PRAC)
  • Label update analysis
  • Preparation of Signal Management Tracker and Annual Signal Reports
• + Local Pharmacovigilance Services in Saudi Arabia
  • Review of PSMF, Safety Data Exchange Agreements (SDEAs), agreements with commercial partners, and pharmacovigilance Standard Operating Procedures (SOPs)
  • Retainer services for LQPPV and Deputy QPPV
  • Medical review of signal detection and participation in Signal Surveillance Meetings
  • Provision of monthly communication reports and compliance metrics
  • Oversight of Pharmacovigilance Quality Management Systems
• + Pharmacovigilance Audit & Compliance
  • Review of compliance with applicable pharmacovigilance guidelines, regulations, SDEAs, SOPs, and work instructions
  • Optimization of audit plans and conduct of mock audits
  • Regular gap assessments of pharmacovigilance staff
  • Provision of organizational training on safety audits and inspections