ICH Efficacy Guidelines from E1 to E20

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.

ICH Efficacy Guidelines from E1 to E20

Click on the titles below for complete guidelines

E1 Clinical Safety for Drugs used in Long-Term Treatment

E2A - E2F Pharmacovigilance

E3 Clinical Study Reports

E4 Dose-Response Studies

E5 Ethnic Factors

E6 Good Clinical Practice

E7 Clinical Trials in Geriatric Population

E8 General Considerations for Clinical Trials

E9 Statistical Principles for Clinical Trials

E10 Choice of Control Group in Clinical Trials

E11 - E11A Clinical Trials in Pediatric Population

E12Clinical Evaluation by Therapeutic Category

E14 Clinical Evaluation of QT

E15 Definitions in Pharmacogenetics / Pharmacogenomics

E16 Qualification of Genomic Biomarkers

E17 Multi-Regional Clinical Trails

E18 Genomic Sampling

E19 Safety Data Collection

E20 Adaptive Clinical Trails

ICH Efficacy Guidelines from E1 to E20: