Guideline on good pharmacovigilance practices (GVP) – Module VIII – Post-authorisation safety studies
✅ GVP Module VIII – Post-Authorization Safety Studies (PASS)
📘 Purpose
GVP Module VIII provides guidance on the design, conduct, and reporting of Post-Authorization Safety Studies (PASS) conducted by Marketing Authorization Holders (MAHs) after a product has been approved.
PASS are critical tools for further evaluating a medicine’s safety profile in the real world.
🔹 What is a PASS?
A Post-Authorization Safety Study is:
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A pharmacovigilance study conducted after a medicinal product has been authorized.
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Aimed at identifying, characterizing, or quantifying safety hazards, risk factors, or confirming the safety profile.
🔹 Types of PASS
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Non-interventional PASS
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Observational in nature (e.g., using registries, healthcare databases)
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No change to standard medical care
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Most common type of PASS in the EU
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Interventional PASS
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Involve interventions not part of routine care
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Require regulatory approvals similar to clinical trials
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🔹 When Are PASS Required?
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As a specific obligation (e.g., conditional approval or risk minimization).
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As a voluntary study by the MAH.
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Following identification of a safety signal.
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When additional data is needed to better understand a risk.
🔹 Objectives of PASS
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Confirm or refute a safety signal.
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Quantify risks in subpopulations (e.g., elderly, pregnant women).
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Evaluate patterns of drug utilization.
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Assess long-term safety or rare adverse events.
🔹 PASS Protocols and Submissions
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Study protocols must be:
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Submitted to PRAC for assessment (if imposed as an obligation).
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Approved prior to study start.
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Protocol and report submissions go through the EU PAS Register or CTIS (for interventional).
🔹 Reporting Requirements
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Final study reports must be submitted within 12 months of study end.
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Progress reports may be required depending on regulatory obligations.
🔹 Supervision & Oversight
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EMA/PRAC oversees centrally authorized products.
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National Competent Authorities (NCAs) supervise others.
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PRAC may issue scientific advice or recommend regulatory actions based on PASS findings.
🔹 Transparency
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Mandatory registration of studies in the EU PAS Register.
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Public availability of protocols and results enhances scientific transparency and trust.
🔹 Quality Standards
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PASS must follow Good Pharmacoepidemiology Practices (GPP) and comply with legal obligations under:
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Directive 2001/83/EC
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Regulation (EC) No 726/2004
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📌 Conclusion
PASS are a vital part of the pharmacovigilance system, supporting continuous benefit-risk monitoring after a drug enters the market.
They help gather real-world evidence to protect public health and ensure informed regulatory decisions.
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