• Pharmacogenomics E15 - E16

    Code Document Title Previously coded
    • Finalised Guideline:
      November 2007

      Description:

      The harmonised tripartite Guideline was finalised under Step 4 in November 2007. This Guideline contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics and genomic data and sample coding categories. The validation and qualification processes for genomic biomarkers, evidence for their intended use and acceptance criteria across ICH regions are outside of the scope of this guideline. As new scientific knowledge in the discipline of pharmacogenomics and pharmacogenetics emerges, the current guidance will be reviewed and expanded if appropriate.

      Implementation:

      Step 5

      EU:

      Approved by CHMP in November 2007, issued as EMEA/CHMP/ICH/437986/2006

      MHLW:

      Adopted 9 January 2008, PFSB/ELD Notification No. 0109013 & PFSB/SD Notification No. 0109002

      FDA:

      Published in the Federal Register, 8 April 2008, Vol. 73, No. 68, p. 19074-76