Doctors Clinic

The list of new safety and effectiveness reviews has been updated and now includes safety reviews initiated between February 1 and 28, 2026. The next update is scheduled for May 2026.

Health Canada has published an updated Guidance on how to interpret significant change of a medical device. This update clarifies Health Canada’s current interpretation of what constitutes a significant change for Class III and Class IV medical devices.

Content Product Monograph update: Stivarga (regorafenib); Notice of authorization with conditions: Voxzogo (vosoritide for injection)

The data presented in the Canada Vigilance Adverse Reaction Online Database has been updated and now includes information received by Health Canada up to November 30, 2025. The next update of data is scheduled for early April, 2026.

The list of new safety and effectiveness reviews has been updated and now includes safety reviews initiated between January 1 and 31, 2026. The next update is scheduled for April 2026.

Announcement: Notice of intent to control zuranolone under the Controlled Drugs and Substances Act; Announcement: New clinical information resource on cannabis for medical purposes; PM update: Accutane, Epuris and Absorica LD (isotretinoin); Notice of authorization with conditions: Hyrnuo (sevabertinib): Notice of authorization with conditions: Ziihera (zanidatamab for injection); Medication Error Alert: Psyllium and the risk of choking

The intent of this notice is to clarify Health Canada’s expectations regarding the reporting of cases identified from the Canada Vigilance (CV) Adverse Reaction (AR) Online Database by MAHs. In particular, this notice replaces section 4.3 of the Reporting Adverse Reactions to Marketed Health Products – Guidance Document for Industry (2018) and the Notice to Industry (2020).