The International Council for Harmonisation (ICH): 'E' group of guidelines

Below is the overview of 'E' group of ICH guidelines that collectively apply to different stages and types of pre- / clinical research and development.


ICH: ‘E’ group of guidelines overview


General Considerations for Clinical Studies:

E 8 (R1) ICH Consensus Guideline


Design and Analysis:

E4 Dose-Response Studies

E9 Statistical principles for Clinical Trials

E10 Choice of Control Group in Clinical Trials

E17 Multi-Regional Clinical Trials

Conduct and Reporting:

E3 Clinical Study Reports

Safety Reporting:

E1 Clinical Safety for Drugs used in Long-Term Treatment

E2A – E2F Pharmacovigilance

E14 Clinical Evaluation of QT

E19 Safety Data Collection



E5 Ethnic Factors

E7 Clinical Trials in Geriatric Population

E11 – E11A Clinical Trials in Pediatric Polulations

E12 Clinical Evaluation by Therapeutic Category

Genetics / Genomics

E15 Definitions in Pharmacogenetics/Pharmacogenomics

E16 Qualification of Genomic Biomarkers

E18 Genomic Sampling


Other EU Guidelines:

Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol



Author: European Medicines Agency

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