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Health Canada Implements ICH Guidance on Good Clinical Practice
Drugs Regulatory Affairs
Health Canada announced the implementation of International Council for Harmonization guidance E6(R2) on good clinical practice.
The agency says the ICH document should be read in conjunction with other applicable Health Canada guidances. But it notes that the scope and subject matter of the agency’s current guidances may not be entirely consistent with those of the ICH guidances.
In these situations, Health Canada-implemented ICH guidances will take precedence. The agency said it will amend or withdraw existing guidances as needed.