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The Periodic Benefit-Risk Evaluation Report (PBRER) described in this Guideline is intended to be a common standard for periodic benefit-risk …
Section C.01.018 of Division 1 of the Food and Drug Regulations requires the Market Authorization Holder (MAH) to analyze adverse …
The Health Product Vigilance Framework is being developed to strengthen and modernize health product vigilance (PV) practices in Canada. Aligned …
To provide market authorization holders direction on the process to be followed and information to be submitted to Health Canada …
The purpose of this Notice is to notify stakeholders that Health Canada has made changes to the opioid patient information …
Health Canada has identified the need for patients to receive clear information about the safe use of opioids and the …
This guidance is intended to harmonize and to update the prescribing information for nonsteroidal anti-inflammatory drugs () indicated for controlling …
This document provides information for industry on how Health Canada's Health Products and Food Branch interprets and applies the 2014 …
This document provides information for industry on how Health Canada's Health Products and Food Branch interprets and applies the 2014 …
The Guidance Document: Management of Drug Submissions and Applications (MDSG) gives sponsors and Health Canada staff operational direction and guidance …