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International Council for Harmonisation (ICH) Guidelines

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global body that develops harmonized guidelines for drug development and pharmacovigilance. ICH guidelines are widely adopted by regulatory authorities worldwide, including the FDA, EMA, and PMDA.

  • ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
    • Provides definitions and standards for expedited reporting of adverse drug reactions during clinical trials.
    • Establishes timelines and reporting criteria for serious adverse events (SAEs) and other safety data.
  • ICH E2E: Pharmacovigilance Planning
    • Introduces the concept of a pharmacovigilance plan (PVP), which outlines the strategies for monitoring and managing risks associated with a drug throughout its lifecycle.
    • Recommends the development of risk management plans (RMPs) for new medicines and significant new indications.
  • ICH E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
    • Provides guidance on the management of post-approval safety data, including the identification and reporting of adverse drug reactions (ADRs).
    • Establishes criteria for expedited reporting of serious and unexpected ADRs.
  • ICH E2C(R2): Periodic Benefit-Risk Evaluation Report (PBRER)
    • Replaces the Periodic Safety Update Report (PSUR) with the PBRER, emphasizing a benefit-risk evaluation approach.
    • Requires regular submission of PBRERs to regulatory authorities, summarizing the global safety experience of a drug over a specific period.

In addition to ICH guidelines, the European Union’s Good Pharmacovigilance Practices (GVP) provide comprehensive instructions on conducting pharmacovigilance activities within member states..

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