ICH

Health Canada, as official observer to and active participant in the International Conference on Harmonisation (ICH), is committed to the adoption and implementation of ICH guidances and standards.

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.

In the past, Health Canada did not, in general, publish ICH guidances as Health Canada adopted guidances until such time that a fixed date could be established for the coming into effect of the guidance. This led to uncertainty regarding Health Canada's position on the acceptability of certain guidances.

Health Canada will now move 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.