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..
