ICH Efficacy Guidelines

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/ pharmacogenomics techniques to produce better targeted medicines.

E1 Clinical Safety for Drugs used in Long-Term Treatment:

E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions

E2A-E2F Pharmacovigilance:

E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

E2B(R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports

E2C(R2) Periodic Benefit-Risk Evaluation Report

E2C(R2) Q&As Questions & Answers: Periodic Benefit-Risk Evaluation Report

E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting

E2E Pharmacovigilance Planning

E2F Development Safety Update Report

E3 Clinical Study Reports:

E3 Structure and Content of Clinical Study Reports

E3 Q&As (R1) Questions & Answers: Structure and Content of Clinical Study Reports

E4 Dose-Response Studies:

E4 Dose-Response Information to Support Drug Registration

E5 Ethnic Factors:

E5(R1) Ethnic Factors in the Acceptability of Foreign Clinical Data

E5 Q&As (R1) Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data

E6 Good Clinical Practice:

E6(R1) Good Clinical Practice

E7 Clinical Trials in Geriatric Population:

E7 Studies in Support of Special Populations: Geriatrics

E7 Q&As Questions & Answers: Studies in Support of Special Populations : Geriatrics

E8 General Considerations for Clinical Trials:

E8 General Considerations for Clinical Trials

E9 Statistical Principles for Clinical Trials:

E9 Statistical Principles for Clinical Trials

E9(R1) Addendum: Statistical Principles for Clinical Trials

E10 Choice of Control Group in Clinical Trials:

E10 Choice of Control Group and Related Issues in Clinical Trials

E11-E11A Clinical Trials in Pediatric Population:

E11(R1) Addendum:Clinical Investigation of Medicinal Products in the Pediatric Population

E11A EWG Paediatric Extrapolation

E12 Clinical Evaluation by Therapeutic Category:

E12Principles for Clinical Evaluation of New Antihypertensive Drugs

E14 Clinical Evaluation of QT:

E14 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs

E14 Q&As (R3) Questions & Answers: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs

E14/S7B DG Questions & Answers:The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Discussion Group

E15 Definitions in Pharmacogenetics / Pharmacogenomics:

E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories

E16 Qualification of Genomic Biomarkers:

E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions

E17 Multi-Regional Clinical Trials:

E17 General principle on planning/designing Multi-Regional Clinical Trials

E18 Genomic Sampling:

E18 Genomic Sampling and Management of Genomic Data

E19 Safety Date Collection:

E19 A Selective Approach to Safety Date Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials

E20 Adaptive Clinical Trials:

E20 EWG Adaptive Clinical Trials

E21 Inclusion of Pregnant and Breastfeeding Individuals in Clinical:

E21 Iinformal WG Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

Source from ICH