ICH Guidelines for Pharmacovigilance

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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

🔹 E2AExpedited Reporting (Clinical Phase)

  • Defines serious and unexpected adverse drug reactions.

  • Sets standards for timing and content of safety reports during clinical trials.

  • Applicable before product approval.

🔹 E2B(R3)ICSR Electronic Format

  • Standardizes electronic submission of individual case safety reports (ICSRs).

  • Ensures structured, consistent data across global PV systems (e.g., EudraVigilance, FDA, PMDA).

🔹 E2C(R2)PBRER

  • Comprehensive periodic safety report, including:

    • Benefit-risk evaluation

    • Safety signals

    • Risk minimization activities

  • Submitted every 6 months, annually, or as requested post-approval.

🔹 E2DPost-Approval Expedited Reporting

  • Clarifies which serious adverse events require rapid notification to regulatory authorities.

  • Distinct from E2A by focusing on marketed products.

🔹 E2EPharmacovigilance Planning

  • Introduces Risk Management Plan (RMP).

  • Requires identifying important risks, missing information, and minimization strategies.

  • Links safety planning with pre- and post-authorization phases.

🔹 E2FDevelopment Safety Update Report (DSUR)

  • Annual safety report during clinical development.

  • Combines data from all ongoing trials under an Investigational New Drug (IND).

  • 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

  • E2A: Defines serious AEs & clinical trial reporting.

  • E2B(R3): XML-based electronic reporting of ICSRs.

  • E2C(R2): PBRER – benefit-risk focused safety report post-approval.

  • E2D: Expedited reporting for marketed drugs.

  • E2E: Risk management planning and safety strategy.

  • E2F: DSUR – annual safety reporting in development phase.

 

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