Health Canada

Health Canada develops food safety and nutritional regulations, policies and guidance under the Food and Drugs Act. This act governs the safety and nutritional quality of food sold in Canada.

It presents the Patent Act Schedules #1, #2, #3 and #4.

Canada's Access to Medicines Regime is intended to address public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other diseases.

Canada's Access to Medicines Regime provides a framework within which eligible countries can import less expensive generic versions of patented drugs and medical devices.

This document provides guidance on the study and analysis of sex differences in clinical trials of therapeutic products in order to generate evidence to advise on the optimal use of therapeutic products in both women and men.

The purpose of this guidance document is to give drug and medical device manufacturers instructions on how to prepare clinical information documents for release and give members of the public instructions on how to request this information.

It presents WTO-Member Countries Eligible to Import Under the Regime

Governments can override patent rights when necessary. In such instances, the government authorizes a third party to use the patented invention without the patent holder's permission. This authorization comes in the form of a compulsory licence.

Countries with insufficient or no manufacturing capacity in the pharmaceutical sector can benefit from participating in Canada's Access to Medicines Regime. Under the Regime, eligible countries can import less expensive, generic versions of patented products manufactured in Canada.

We are working to make clinical information about the safety and efficacy of drugs and medical devices available to the public. Information that Health Canada currently treats as confidential would be made publicly available following a final regulatory decision.

For the purpose of this guidance document, Health Canada has determined that certain submissions and applications involving human or disinfectants drugs may be submitted for administrative processing as they do not contain scientific data.

The Special Access Programme (SAP) provides access to nonmarketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise...

The updated regulations will help drug makers understand what information should be included in their drug submissions. This will help with product approval and availability.

This project will build new review pathways for those drugs shown to meet health care system needs. The outcome for the people of Canada will be faster access to drugs, including drugs for rare diseases.

This project will result in Health Canada and Health Technology Assessment (HTA) organizations working together. This will allow them to give scientific advice to manufacturers at the same time early in the drug development process.

The Health Canada and Health Technology Assessment (HTA) review processes are independent of each other. Aligned reviews project will make sure that the timing of Health Canada and Canadian HTA reviews are better aligned.

These amendments would introduce a regulatory framework for Drug Shortages within the Food and Drug Regulations.

Below are some of the unique features of Canada's Access to Medicines Regime, many of which resulted from negotiations between the Government of Canada, the private sector and various non-governmental organizations.

It presents WTO-Member Countries and Non-WTO Member Countries Eligible to Import Under the Regime.

It presents the list Least-Developed Countries Eligible to Import Under the Regime.