Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report
✅ GVP Module VII – Periodic Safety Update Report (PSUR)
📘 Purpose
GVP Module VII provides guidance on the preparation, submission, and assessment of Periodic Safety Update Reports (PSURs) by Marketing Authorization Holders (MAHs).
It ensures the continuous benefit-risk evaluation of a medicinal product throughout its lifecycle.
🔹 What is a PSUR?
A Periodic Safety Update Report is a pharmacovigilance document intended to:
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Provide an update on the worldwide safety experience of a product.
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Evaluate the risk-benefit balance.
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Include new safety information and signal evaluation.
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Recommend safety-related changes (if needed).
🔹 Objectives of PSURs
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Describe the product’s safety profile over a defined period.
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Assess new or changing risks.
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Identify whether further risk minimization is required.
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Ensure proactive signal detection and management.
🔹 Scope
Applies to:
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Centrally and nationally authorised medicinal products in the EU.
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Both generic and innovator products (though reporting requirements vary).
🔹 PSUR Contents (ICH E2C(R2) Structure)
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Introduction
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Worldwide Marketing Authorization Status
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Actions Taken for Safety Reasons
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Changes to Reference Safety Information
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Estimated Patient Exposure
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Data in Summary Tabulations
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Summaries of Significant Findings
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Signal and Risk Evaluation
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Benefit Evaluation
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Integrated Benefit-Risk Analysis
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Conclusions and Actions
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Appendices (e.g., line listings)
🔹 Submission Frequency
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Based on EU PSUR submission schedule (EURD list).
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Usually:
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First 2 years: every 6 months
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Next 2–3 years: annually
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Thereafter: every 3–5 years unless otherwise required
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🔹 Assessment Process
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PSURs are submitted to EMA (via PSUR Repository) or NCAs.
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EMA/NCA assesses the benefit-risk balance and may recommend:
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Labelling changes
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Additional studies
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Risk minimization activities
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🔹 PSUR Repository (EU)
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A central platform for submission and review of PSURs in the EU.
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Mandatory for centrally authorised products; voluntary for others.
🔹 Quality and Compliance
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PSURs must be complete, scientifically robust, and timely.
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MAHs should have SOPs and trained staff for PSUR preparation.
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Late or non-submission is a regulatory non-compliance.
🔹 Conclusion
PSURs are key tools in proactive pharmacovigilance.
They help regulators and MAHs ensure that the product’s benefit-risk profile remains favourable, enabling safe use in real-world settings.
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