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ICH GuidelineStatusDate
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E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening ConditionsStep 51994-10-27
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E10 Choice of Control Group and Related Issues in Clinical TrialsStep 52000-07-20
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E11(R1) Clinical Investigation of Medicinal Products in the Pediatric Population: Guideline and AddendumStep 52017-08-18
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E11A EWG Paediatric ExtrapolationStep 52024-08-21
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E12 Principles for Clinical Evaluation of New Antihypertensive Drugs
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E14 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic DrugsStep 52005-05-12
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E14 Q&As (R3) Questions & Answers: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic DrugsStep 52015-12-10
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 E14/S7B IWG Questions and Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Discussion Group
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E14/S7B IWG Questions & Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic PotentialStep 52022-02-21
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E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding CategoriesStep 52007-11-01
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E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification SubmissionsStep 52010-08-20
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E17 General principles for planning and design of Multi-Regional Clinical TrialsStep 52017-11-16
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E18 Genomic Sampling and Management of Genomic DataStep 52017-09-06
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E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical TrialsStep 52022-09-27
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E20 EWG Adaptive Clinical TrialsStep 1
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E2A Clinical Safety Data Management: Definitions and Standards for Expedited ReportingStep 51994-10-27
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E2B(R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs)Step 52012-11-01
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E2B(R3) EWG/IWG Electronic Transmission of Individual Case Safety Reports (ICSRs)
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E2B(R3) Q&As Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety ReportsStep 52023-01-17
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E2C(R2) Periodic Benefit-Risk Evaluation ReportStep 52012-12-17
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E2C(R2) Q&As Questions & Answers: Periodic Benefit-Risk Evaluation ReportStep 52014-03-31
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E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited ReportingStep 52003-11-12
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E2D(R1) EWG Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety ReportsStep 4
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E2E Pharmacovigilance PlanningStep 52004-11-18
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E2F Development Safety Update ReportStep 52010-08-17
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E3 Structure and Content of Clinical Study ReportsStep 51995-11-30
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E3 Q&As (R1) Questions & Answers: Structure and Content of Clinical Study ReportsStep 52012-07-06
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E4 Dose-Response Information to Support Drug RegistrationStep 51994-03-10
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E5 Q&As (R1) Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical DataStep 52006-06-02
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E5(R1) Ethnic Factors in the Acceptability of Foreign Clinical DataStep 51998-02-05
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E6(R2) Good Clinical Practice (GCP)Step 52016-11-10
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E6(R3) Annex 2 Sub-group
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E6(R3) EWG Good Clinical Practice (GCP)Step 32023-05-19
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E7 Studies in Support of Special Populations: GeriatricsStep 51993-06-24
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E7 Q&As Questions & Answers: Studies in Support of Special Populations : GeriatricsStep 52010-07-16
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E8 General Considerations for Clinical TrialsStep 51997-07-17
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E8(R1) General Considerations for Clinical StudiesStep 52021-10-06
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E9 Statistical Principles for Clinical TrialsStep 51998-02-05
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E9(R1) Addendum: Statistical Principles for Clinical TrialsStep 52019-11-20
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