ICH Guidelines for Clinical Safety

The International Council for Harmonisation (ICH) develops harmonised guidelines that support the quality, safety and efficacy of medicines. Within the ICH Efficacy guidelines, the E2 series provides an important framework for clinical safety data management and pharmacovigilance throughout the lifecycle of a medicinal product.

The current guideline portfolio is available through the ICH Efficacy Guidelines.

For background on ICH and its wider guideline framework, see International Council for Harmonisation (ICH).

ICH Guidelines for Clinical Safety: E2A

ICH E2A establishes definitions and standards for expedited reporting of adverse drug reactions during clinical development. It provides important concepts relating to adverse events, adverse drug reactions, seriousness, expectedness and expedited safety reporting.

ICH E2B(R3) – Individual Case Safety Reports

ICH E2B(R3) defines data elements and technical standards for the electronic transmission of Individual Case Safety Reports (ICSRs). It supports structured exchange of pharmacovigilance information between pharmaceutical companies, regulatory authorities and other stakeholders.

ICH E2C(R2) – Periodic Benefit-Risk Evaluation Report

ICH E2C(R2) provides the framework for the Periodic Benefit-Risk Evaluation Report (PBRER). The PBRER supports periodic evaluation of cumulative safety information and the overall benefit-risk profile of an authorised medicinal product.

ICH Clinical Safety Guideline E2D(R1)

ICH E2D(R1) provides definitions and standards for post-approval safety data management and individual case safety reporting. The revised guideline reflects developments in pharmacovigilance practices and provides updated guidance for managing safety information after a product has been authorised.

ICH E2E – Pharmacovigilance Planning

ICH E2E provides guidance on pharmacovigilance planning, including the identification of important identified and potential risks, missing information and the planning of appropriate pharmacovigilance activities.

ICH E2F – Development Safety Update Report

ICH E2F establishes the Development Safety Update Report (DSUR), which provides a periodic review and analysis of safety information collected during the clinical development of an investigational medicinal product.

Together, the ICH E2 clinical safety guidelines support consistent collection, evaluation, reporting and communication of safety information during clinical development and after marketing authorisation. They contribute to internationally harmonised pharmacovigilance practices while recognising that specific reporting requirements may vary between regulatory jurisdictions.

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