International Council for Harmonisation (ICH)

Health Canada role in ICH

Health Canada, as an official member to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), is committed to the implementation of all ICH guidelines 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.

Consistent with the ICH guideline development process, Health Canada solicits comments on draft (Step 2) guidelines. Comments received are forwarded to the relevant ICH working group for consideration in the finalisation of the guideline. Finalised (Step 4) ICH documents are made available to the public on the ICH website following endorsement by the ICH Assembly. Once implemented by Heath Canada, ICH guidelines become official Health Canada guidance documents.

The coming into effect of ICH guidelines 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 guidelines on stakeholders may also influence the effective date of such guidelines in Canada.

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