ICH E16 Genomic biomarkers related to drug response: context, structure and format of qualification submissions - Scientific guideline

This document describes the context, structure, and format of qualification submissions for clinical and nonclinical genomic biomarkers related to development of drug or biotechnology products including translational medicine approaches, pharmacokinetics, pharmacodynamics, efficacy and safety aspects.

Keywords: Genomic biomarkers

Current effective version

ICH guideline E16: Genomic biomarkers related to drug response: context, structure and format of qualification submissions - Step 5

Adopted Reference Number: EMA/CHMP/ICH/380636/2009 Legal effective date: 01/12/2010 Summary:

The guideline describes recommendations regarding context, structure and format of regulatory submissions for qualification of genomic biomarkers (as defined in ICH E15).

Document history - First version (current)

ICH guideline E16: Genomic biomarkers related to drug response: context, structure and format of qualification submissions - Step 5

Adopted Reference Number: EMA/CHMP/ICH/380636/2009 Legal effective date: 01/12/2010 Summary:

The guideline describes recommendations regarding context, structure and format of regulatory submissions for qualification of genomic biomarkers (as defined in ICH E15).

ICH: E 16: Note for guidance on genomic biomarkers related to drug response: context, structure and format of qualification submissions - Step 3

Draft: consultation closed Reference Number: EMEA/CHMP/ICH/380636/2009