ICH Expert Working Groups issue updated technical documents for three guidelines

21st January 2026

ICH Expert Working Groups issue updated technical documents for three guidelines

Summary: On 15th January 2026, the ICH announced that three Expert Working Groups have released updated materials linked to important guidelines:

• ICH E2B (R3) (Individual Case Safety Report Specification): An Information Paper and an updated Implementation Guide Package (with code lists) were published to explain alignment with the recently updated E2D post-approval safety reporting guideline, aiding consistent electronic safety data exchange.

• ICH M4Q (R2) (Common Technical Document – Quality): A Mapping Document was issued to help industry and regulators understand changes between the original M4Q and the updated M4Q (R2) draft, clarifying how quality-section content should be presented in registration dossiers.

• ICH E6 (R3) (Good Clinical Practice): A Module 4 training module on Informed Consent has been published to support understanding of the revised GCP guideline, focusing on this ethical cornerstone of clinical trials.

These documents do not change the guidelines themselves but provide practical support and harmonised interpretation, enhancing clarity for sponsors, regulators and other stakeholders implementing ICH standards globally.

Link: https://www.ich.org/news/updated-technical-documents-issued-ich-expert-working-groups-three-guidelines

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