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Drugs and Health Products

International Council for Harmonisation (ICH)

Health Canada, as official member to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), is committed to the adoption and implementation of ICH guidances and standards. The Council was officially established on October 23, 2015, following 25 years as the International Conference on Harmonisation which transforms ICH into a truly global initiative supported by a robust and transparent governance structure. Complete details about the reorganisation of ICH can be found on the ICH website.

Consistent with the ICH guidance development process, Health Canada solicits comments on draft (or Step 2) guidances. Comments received are forwarded to the relevant ICH working group for consideration in the finalization of the guidance. Finalized (Step 4) ICH documents are made available to the public on the ICH website following endorsement by the ICH Steering Committee. Once adopted by Heath Canada, ICH guidances become official Health Canada guidances.

The coming into effect of ICH guidances by Health Canada may at times be affected by the need to undertake certain activities including collateral guidance and policy work, training, staffing, business process changes and/or regulatory amendment. The potential impact of ICH guidances on stakeholders may also influence the effective date of such guidances in Canada.

Health Canada will continue to adopt ICH guidances once routine administrative steps have been completed. In exceptional situations where an effective date cannot be established at the time of adoption and publication by Health Canada, an explanatory statement to this effect will be included in the covering notice and the title page of the guidance.