Issue Date: August 11, 2011
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Efficacy
Status: Final
E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions
The guidance describes recommendations regarding context, structure and format of regulatory submissions for qualification of genomic biomarkers (as defined in ICH E15 3). 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 postapproval. A biomarker qualification application might be submitted to regulatory authorities if the biomarker directly or indirectly helps in regulatory decision-making.
Download the Guidance Document
