Health Canada Opens Consultation on Mandatory Adverse Drug Reaction, Device Incident Reports

Health Canada on Tuesday opened up a consultation on changes to the country’s Food and Drug Regulations and Medical Devices Regulations that would make it mandatory for certain health care institutions to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs).

“Reports about serious ADRs and MDIs can be important signals of emerging safety issues. Such post-market observations can also lead to improved safety information about a product,” the regulator said.

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