Health Canada

This process map provides a visual overview of the steps that need to be followed by a pharmaceutical company that is preparing to submit an application for a compulsory licence under Canada's Access to Medicines Regime.

To participate in the Regime, a pharmaceutical company must enter into a sales agreement with an eligible importing country for the purchase of a specified amount of an eligible product listed on Schedule 1. A pharmaceutical company must also submit an application for authorization to Canada's...

This section contains additional information and documentation.

In August 2003, negotiations among World Trade Organization (WTO) members resulted in a landmark decision to waive two licensing provisions of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) that appeared to prevent the export of generic drugs and medical...

This document outlines the strategy and provides guidance for the medical device industry on Health Canada's compliance and enforcement activities.

This guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements in relation to Medical Device Establishment Licences (MDEL), including when and how to apply for an MDEL, and how to maintain an MDEL once issued.

Canada's Access to Medicines Regime provides a way for the world's developing and least-developed countries to import high-quality drugs and medical devices at a lower cost to treat the diseases that bring suffering to their citizens.

The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the national authority that monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada.

The term Medical Devices covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. This guide provides information on how medical devices are approved and authorized in Canada.

These inspection and investigation functions have as main objective to reduce risks to subjects enrolled in clinical trials, while encouraging sponsors in their research activities for new therapies.

We are updating how we disclose the clinical information used to assess the safety and effectiveness of drugs and medical devices.

Drug and medical device manufacturers submit clinical information to Health Canada for the approval of new products. Health Canada assesses this clinical information to reach a decision on whether or not to approve a drug or medical device.

Before a drug is authorized for sale in Canada, it must be issued a DIN in accordance with the Food and Drug Regulations. Also in accordance with the Food and Drug Regulations, a manufacturer of a drug must annually, before October 1, notify Health Canada that the drug is still on the market and...

These guidelines are meant to help companies in the drug manufacturing industry and health care professionals understand how to comply with regulations, specifically drug establishment licence (DEL) requirements in Part C, Division 1A of the FDR.

Health Canada's drug products fact sheet describes how drugs are reviewed in Canada including how drugs are developed and submitted for authorization to conduct clinical trial.

How to access a list of generic drug submissions currently under review.

For eligible submissions accepted into review on or after October 1, 2018, the submission 'class' added to the Lists of submissions currently under review.

Present the list of new drug submissions (NDSs) that are currently being reviewed.

Understand the decisions to approve or not approve the sale of drugs and medical devices in Canada.

Drug shortages can occur for any number of reasons and can result from problems at any point in the drug supply chain.