ICH Guidelines for Pharmacovigilance
Here is a comprehensive list and explanation of ICH Guidelines related to Pharmacovigilance, which aim to harmonize safety monitoring practices across regulatory regions:
✅ Core ICH Guidelines for Pharmacovigilance
| Code | Title | Focus Area |
|---|---|---|
| E2A | Clinical Safety Data Management: Definitions and Standards for Expedited Reporting | Defines serious adverse events (SAEs) and criteria for expedited reporting. |
| E2B (R3) | Data Elements for Transmission of Individual Case Safety Reports (ICSRs) | Specifies electronic format (XML) and structure of ICSRs. |
| E2C (R2) | Periodic Benefit-Risk Evaluation Report (PBRER) | Provides format for periodic reporting post-marketing. Replaces PSUR in many regions. |
| E2D | Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting | Expedited reporting after drug approval; harmonizes post-marketing AE reporting. |
| E2E | Pharmacovigilance Planning | Framework for creating a Pharmacovigilance Plan as part of Risk Management System (RMP). |
| E2F | Development Safety Update Report (DSUR) | Annual safety report for drugs in clinical development, combining multiple safety reports across regions. |
📌 Brief Descriptions of Key Guidelines
🔹 E2A – Expedited Reporting (Clinical Phase)
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Defines serious and unexpected adverse drug reactions.
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Sets standards for timing and content of safety reports during clinical trials.
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Applicable before product approval.
🔹 E2B(R3) – ICSR Electronic Format
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Standardizes electronic submission of individual case safety reports (ICSRs).
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Ensures structured, consistent data across global PV systems (e.g., EudraVigilance, FDA, PMDA).
🔹 E2C(R2) – PBRER
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Comprehensive periodic safety report, including:
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Benefit-risk evaluation
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Safety signals
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Risk minimization activities
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Submitted every 6 months, annually, or as requested post-approval.
🔹 E2D – Post-Approval Expedited Reporting
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Clarifies which serious adverse events require rapid notification to regulatory authorities.
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Distinct from E2A by focusing on marketed products.
🔹 E2E – Pharmacovigilance Planning
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Introduces Risk Management Plan (RMP).
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Requires identifying important risks, missing information, and minimization strategies.
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Links safety planning with pre- and post-authorization phases.
🔹 E2F – Development Safety Update Report (DSUR)
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Annual safety report during clinical development.
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Combines data from all ongoing trials under an Investigational New Drug (IND).
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Improves international coordination and transparency of clinical safety.
📎 Supporting Guidelines & Tools
While not directly titled under “E2”, the following ICH guidelines also support pharmacovigilance:
| Guideline | Description |
|---|---|
| M1 | MedDRA (Medical Dictionary for Regulatory Activities) – Standard terminology used in AE reporting. |
| E6 (R2) | Good Clinical Practice (GCP) – Includes requirements for AE collection and safety monitoring in clinical trials. |
| E9 | Statistical Principles for Clinical Trials – Helps with signal detection and risk evaluation. |
🧠 Summary for Interviews or Study
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E2A: Defines serious AEs & clinical trial reporting.
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E2B(R3): XML-based electronic reporting of ICSRs.
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E2C(R2): PBRER – benefit-risk focused safety report post-approval.
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E2D: Expedited reporting for marketed drugs.
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E2E: Risk management planning and safety strategy.
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E2F: DSUR – annual safety reporting in development phase.
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