ICH Guidelines- Efficacy Guidelines

ICH Efficacy Guidelines:

Revised ICH Efficacy Guidelines are listed below:

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
E2B(R3) IWG Implementation: Electronic 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(R2) Good Clinical Practice (GCP)

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(R1) Addendum: Statistical Principles for Clinical Trials (copy 1)
E9 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 Clinical Trials in Pediatric Population 

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

E12 Clinical Evaluation by Therapeutic Category 

E12 Principles 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 Discussion Group on Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation

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 Data Collection

E19 Optimisation of Safety Data Collection

Ref:

ICH Efficacy Guidelines