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Health Canada is pleased to announce the adoption of the ICH guidance E16: Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process.

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Name	Format	Description	Link
Guidance Document - Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions ICH Topic E16	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/efficacy/biomarkers-related-drug-biotechnology-product-development-context-structure-format-qualification-submissions-topic.html
Guidance Document - Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions ICH Topic E16	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/international-conference-harmonisation/efficacite/biomarqueurs-lies-mise-point-medicaments-produits-biotechnologiques-contexte-structure-format-demandes-qualification-theme.html

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