RegulinkedSFDA Just publish new updates regarding Guideline on Good Pharmacovigilance Practices (GVP) – (Version 4.0, August 2025).
🔍 What’s new:
The 2025 update refines roles, processes, and KSA-specific requirements across multiple GVP modules, including:
• Clearer local QPPV rules: full-time, KSA-resident QPPV; deputy arrangements; mandatory registration/notifications via the Saudi Vigilance System.
• PSMF enhancements, including a KSA section on computerized systems/databases.
• Risk Management: updated Saudi-Specific Annex (RMP Annex 9) and requirements at initial MA.
• Case safety reporting: additions on spontaneous reports and updates on emerging safety issues.
• PSUR/PBRER: standard submission schedule added for KSA.
• Signal management: clarified MAH roles and responsibilities.
• Safety communications: updated DHPC processes and a new Annex III guiding joint DHPC letters; guidance on publishing DHPCs.
• Risk-minimization: drafting guide addendum with required documents and format for educational materials.
💡 Why it matters:
GVP v4.0 aligns KSA pharmacovigilance with current global practice while adding precise, enforceable local expectations (QPPV, PSMF, RMP/SSA, DHPCs, PSUR schedules).
For MAHs and applicants, this means tighter oversight, predictable timelines, and a clearer path to sustained benefit-risk management and inspection readiness.
📌 How ReguLinked can support you:
• Establish/upgrade PV systems to GVP v4.0 (PSMF build, KSA-specific sections, SOP suite, KPI dashboards).
• Local QPPV & Deputy setup, credentials, registration, and business-continuity planning.
• RMP authoring with Saudi-Specific Annex; additional RMMs and effectiveness evaluations.
• ICSR management & electronic reporting, signal detection/assessment, and PSUR/PBRER scheduling & submissions.
• DHPC strategy, drafting, joint communications, and publication pathways.
• PASS oversight, PV audit/inspection readiness, and cross-functional training (RA, QA, Medical).
• End-to-end market enablement: eCTD publishing, labeling/artwork compliance, scientific translation, and—where relevant—importation, trading & distribution setup to support post-market safety operations.
📨 Building or upgrading your KSA pharmacovigilance system? Let’s align your PV strategy, documentation, and execution with SFDA GVP v4.0—so you’re inspection-ready and market-confident.
📧 consultation@regulinked.com | 🌐 www.regulinked.com
📎 Access the official SFDA guideline here:
🔗 Guideline on Good Pharmacovigilance Practices (PDF): https://www.sfda.gov.sa/sites/default/files/2025-08/Drug-GVP4_0.pdf
🔗 SFDA Official Website – Drug Sector: https://www.sfda.gov.sa
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