Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Guidance document

This is a public health concern resulting in significant costs to the health care system as well as individual impacts on Canadians. Health Canada's monitoring of therapeutic product safety plays a vital role in public health and patient safety, providing health care providers and patients with the most up-to-date knowledge for decision making. It also provides Health Canada with information needed to monitor the benefit-risk ratio of products and act to protect Canadians where appropriate.