Guidance on management of drug submissions and applications: References

Health Canada has published numerous guidelines, policies and reference documents to help sponsors prepare and file drug submissions and applications. The following list of guidance documents and policies is not exhaustive. These documents should be read along with this guidance document.

General filing

Other filing processes

Labelling

Post-authorization changes

Clinical trials

Medical devices and combination products

Biologics

Pharmacovigilance monitoring

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2025-10-01