Updates to the 2020 product monograph guidance and master template: Closed consultation

From: Health Canada

Health Canada has revised the 2020 product monograph guidance and master template used by drug manufacturers. The updated draft guidance provides more information and guidance on preparing a product monograph for our review and approval.

Who was the focus of this consultation

We engaged with:

• drug manufacturers
• patients in Canada
• healthcare providers

Key questions for discussion

Health Canada looked for input and ideas on:

• making the guidance instructions clearer
• adding technical and policy information

We are using the feedback from this consultation to help us finalize the updated guidance on product monographs and the master template. When the final documents are published, the updated information within these 2 documents will only apply to product monographs that are submitted after final publication.

Contact us

Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Canada

E-mail: bpsip-bpspiconsultation@hc-sc.gc.ca