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

The guideline describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers, as defined in ICH E151. Biomarker qualification has not been covered in any ICH guideline. Qualification is a conclusion that the biomarker data submitted support use of the biomarker in drug discovery, development or post-approval and, where appropriate, in regulatory decision-making. The objective of the guideline is to create a harmonized structure for the qualification of genomic biomarkers that will foster consistency of applications across regions and facilitate joint discussions with and among regulatory authorities.