Share your views: Consultation on the changes to the 2020 product monograph guidance and master template
From: Health Canada
Current status: Open
Opened on September 15, 2023 and will close to new input on November 13, 2023
Health Canada updated the 2020 product monograph guidance and master template to:
- provide more information and guidance for manufacturers when developing a product monograph
- reduce the administrative burden for both industry and regulator when preparing and reviewing a product monograph for approval
We’re holding a consultation on the proposed changes to the following documents:
Join in: how to participate
Send an email with your ideas and comments to bpsip-bpspiconsultation@hc-sc.gc.ca by November 13, 2023.
Who is the focus of this consultation
We want to hear from:
- patients in Canada
- drug manufacturers
- health care providers
Key questions for discussion
We’re seeking your feedback and comments on the changes to the documents. We’ll use the information gathered from this consultation to finalize the updates to both documents. The final revisions made to the Product Monograph Guidance and Master Template will only apply to product monographs that are being submitted after the publication of these two documents.
Contact us
Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Canada
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