INTL · Quality · Efficacy · Safety
ICH
International Council for Harmonisation
10 documents in the Library — regulations, inspection procedures, guidance, Q&As, and reflection papers.
§ 01 — Documents
ICH E2A Clinical Safety Data Management — Definitions and Standards for Expedited Reporting E2A GUIDELINE 1994 PDF · 480 KB ICH E2F Development Safety Update Report NEW E2F GUIDELINE 2011 PDF · — ICH E3 Structure and Content of Clinical Study Reports E3 GUIDELINE 1995 PDF · 1.0 MB ICH E6(R3) Good Clinical Practice — Step 4 Final Guideline E6(R3) GUIDELINE 2025 PDF · 3.1 MB ICH E6(R3) Annex 2 — Non-Traditional Interventional Clinical Trials NEW Draft E6(R3) Annex 2 GUIDELINE 2025 PDF · — ICH E8(R1) General Considerations for Clinical Studies E8(R1) GUIDELINE 2019 PDF · 900 KB ICH E9(R1) Statistical Principles for Clinical Trials — Estimands Addendum E9(R1) GUIDELINE 2019 PDF · 780 KB ICH E17 General Principles for Planning and Design of Multi-Regional Clinical Trials NEW E17 GUIDELINE 2017 PDF · — ICH E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials NEW E19 GUIDELINE 2022 PDF · — ICH E20 Adaptive Designs for Clinical Trials NEW Draft E20 GUIDELINE 2025 PDF · —