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This document provides guidance on brand name assessment, inner and outer product labels, and risk management planning.
This document provides guidance on the standard for accepting a rolling submission and non-clinincal requirements for authorization.
We are collaborating with other national regulatory authorities to align the requirements for evaluating, authorizing and post-market surveillance of variant …
This document provides guidance on establishment licensing, product quality and lot release to bring a COVID-19 vaccine to …
This final report follows a series of consultations that focused on two key Indigenous Languages Act implementation issues: the establishment …
As set out in paragraph C.05.010(b) of the Food and Drug Regulations (FDR), clinical trials must follow certain requirements of …
Many drugs are being evaluated in Canada and around the world as potential treatments for COVID-19. Health …
Producing a vaccine is complex. It requires significant investments to ensure it can be produced on a large scale with …
Clinical trials, or investigational testing, are tests done to look at the safety and effectiveness of a medical device. These …
The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.