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The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines.
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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 Conditions
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E2A - E2F - Clinical Safety Data Management
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E3 - Structure and Content of Clinical Study Reports
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E4 - Dose-Response Information to Support Drug Registration
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E5 - Ethnic Factors in the Acceptability of Foreign Clinical Data
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E6 - Good Clinical Practice (GCP)
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E7 - Studies in Support of Special Populations: Geriatrics
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E8 - General Considerations for Clinical Trials
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E9 - Statistical Principles for Clinical Trials
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E10 - Choice of Control Group and Related Issues in Clinical Trials
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E11 - Clinical Investigation of Medicinal Products in the Pediatric Population
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E12 - Principles for Clinical Evaluation of New Antihypertensive Drugs
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E14 - Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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E15 - Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics
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E16 - Biomarkers Related to Drug or Biotechnology Product Development
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E17 - General principles for planning and design of Multi-Regional Clinical Trials
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E18 - Genomic Sampling and Management of Genomic Data
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E19 - Selective Approach to Safety Data Collection
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E20 - Adaptive Designs for Clinical Trials
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E21 - Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials
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E22 - General Considerations for Patient Preference Studies
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E23 - Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making
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