Guidance Document - Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions ICH Topic E16 (French, HTML)

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Publisher-reported update

2023-12-02

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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