EMA: Scientific guideline: ICH guideline E16 Genomic biomarkers related to drug response: context, structure and format of qualification submissions - Step 4
The guideline describes recommendations regarding context, structure and format of regulatory submissions for qualification of genomic biomarkers (as defined in ICH E15). Qualification is a conclusion that, within the stated context of use, the results of assessment with a biomarker can be relied upon to adequately reflect a biological process, response or event, and support use of the biomarker during drug or biotechnology product development, ranging from discovery through post-approval. A biomarker qualification application might be submitted to regulatory authorities if the biomarker directly or indirectly helps in regulatory decision-making. The objective of the guideline is to create a harmonized recommended structure for biomarker qualification applications that will foster consistency of applications across regions and facilitate discussions with and among regulatory authorities.