Health Canada is the Federal department responsible for helping Canadians maintain and improve their health, while respecting individual choices and circumstances.
Health Canada's goal is for Canada to be among the countries with the healthiest people in the world. To achieve this goal, Health Canada:
Drug Products Page
This section contains fee information, guidance documents, forms and policies needed to submit all the different types of applications.
Medical Devices Page
This section contains fee information, guidance documents, forms and policies needed to submit all of the different types of applications
Access to Therapeutic Products: The Regulatory Process in Canada
This publication describes how therapeutic products in Canada make their way from the laboratory to the marketplace. It explains how Canada's regulatory system facilitates access to safe medical devices, natural health products and drugs, including pharmaceuticals, radiopharmaceuticals, biologics and genetic therapies (for definitions, see Annex I).
Health Products and Food Branch Inspectorate's Compliance and Enforcement Policy (POL-0001) Version 2
The primary role of the Health Products and Food Branch Inspectorate (Inspectorate) is to deliver a national compliance and enforcement program for products under the mandate of the Health Products and Food Branch (HPFB). The Inspectorate's Compliance and Enforcement Policy (POL-0001), Version 2 is the foundation document which describes how it delivers its national compliance and enforcement program. The policy also lays out the roles and responsibilities of regulated parties, consumers and health care professionals in ensuring the safe and effective manufacture and use of health care products.
Canadian GMP Resources
This page contains links to various Canadian resources for Good Manufacturing Practice.