Health Product InfoWatch, October 2025

Content: Announcement: Distribution of the reserve list for antimicrobial drugs via the Canadian Clinical Drug Data Set; Safety Brief: Change in the colour from teal to red for the ferrule / cap of marketed cisatracurium besylate injectable products; Notice of authorization with conditions: Amtagvi

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Draft guidance on preparing and submitting summary reports for marketed drugs and natural health products

Health Canada is holding a 60-day consultation on revisions to the Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products – Guidance Document for Industry, now entitled “Guidance on preparing and submitting summary reports for marketed drugs and natural health products” and the draft form: Notifying Health Canada of a significant change in what is known about the risks and benefits of a product.

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Draft guidance on preparing and submitting summary reports for marketed drugs and natural health products

Health Canada is holding a 60-day consultation on revisions to the Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products – Guidance Document for Industry, now entitled “Guidance on preparing and submitting summary reports for marketed drugs and natural health products” and the draft form: Notifying Health Canada of a significant change in what is known about the risks and benefits of a product.

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