Open Government Portal
Educational module provides overview of health product vigilance, report management, post-market surveillance activities and Health Canada risk communications.
This notice is being issued to clarify to drug manufacturers and sponsors that elements of Risk Management Plans (RMPs) required …
We are issuing this notice to help drug manufacturers and sponsors when preparing the Canadian-specific considerations and elements in the …
Health Canada’s Evolving Approach to Leveraging Real World Evidence (RWE) for Drug Regulatory Decisions.
This guidance document provides market authorization holders (MAHs) with assistance on how to comply with the Food and Drugs Act, …
Health Canada sets the standards for health product advertising material in Canada to help advertisers produce messages that are not …
Learn how Health Canada makes sure that the health products you use are safe, effective and of high quality.
Only health products that Health Canada authorizes for sale in Canada may be advertised. Specific requirements exist for advertisements of …
Health Canada has adopted and integrated the use of risk management plans (RMPs) and the International Conference on Harmonization (ICH) …
Information on risk management plan submissions for drugs including when to file, considerations, requirements, and compliance.