Health Canada

Health Canada has made changes to the policy on drug good manufacturing practices (GMP) and drug establishment licence (DEL) enforcement (POL-0004). This policy supports the consistent and transparent application of compliance and enforcement actions under Canada’s GMP and DEL regulatory schemes.

In 2017, we did a proactive compliance monitoring project to check how 23 companies followed NHP GMPs.

It is an annex to the latest version of the Good manufacturing practices guide for drug products (GUI-0001) and Good manufacturing practices for active pharmaceutical ingredients (API) (GUI-0104).

Summary of the Mutual Recognition Agreement (MRA) Evaluation Guide

A drug shortage is when a drug manufacturer isn't able to supply enough of a drug to meet all of its Canadian orders on time. The role of health care providers in addressing drug shortages.

A drug shortage is when a drug manufacturer isn't able to supply enough of a drug to meet all of its Canadian orders on time. Industry's role in addressing drug shortages.

Drug shortages are a complex, global problem involving all stakeholders across the drug supply chain. The Multi-Stakeholder Steering Committee on Drug Shortages (MSSC) was assembled in 2012 to address drug shortages at the national level.

The Food and Drug Regulations (FDR) contain provisions that help to safeguard the Canadian drug supply. The regulatory provisions are one part of Canada's overall multi-stakeholder toolkit to help prevent and mitigate drug shortages. Compliance and enforcement actions related to these provisions...

This document is for anyone involved in the fabrication, packaging/labelling, testing, importation, distribution and wholesaling of drugs. It describes how to properly qualify and validate drug manufacturing processes, facilities, equipment, utilities and analytical methods.

This document is for anyone involved in the fabrication, packaging/labelling, testing, importation, distribution and wholesaling of drugs. It describes how to properly qualify and validate drug manufacturing processes, facilities, equipment, utilities and analytical methods.

This page provides a summary of Health Canada's Regulatory Operation and Enforcement Branch international collaboration on medicines between Canada and International partners.

Drugs made in Canada or abroad must meet high safety and quality standards before they can be sold to Canadians. Health Canada licenses and regularly inspects companies that make, package, test, import, distribute and wholesale drugs.

Fentanyl is a very potent opioid pain reliever. A few grains can be enough to kill you. Fentanyl is usually used in a hospital setting. A doctor can also prescribe it to help control severe pain.

Naloxone is a fast-acting drug used to temporarily reverse the effects of opioid overdoses. Naloxone only works if you have opioids in your system.

GHB (gamma hydroxybutyrate) is a substance naturally present in your body. It acts as a depressant, slowing and calming the activity of your nervous system. In Canada, doctors can prescribe GHB for narcolepsy (a serious sleep disorder). However, it can also be made in illegal labs and sold...

Heroin is made from morphine, a substance that comes from the opium poppy. It is highly addictive. The withdrawal symptoms can be painful. An overdose can be fatal.

Ketamine is a fast-acting anesthetic used in medical or veterinary surgery. If misused, it can cause harmful and long-lasting effects.

LSD is a potent hallucinogenic drug. It is made from lysergic acid, which is found in a fungus that grows on rye and other grains. LSD can have long-lasting impacts on your brain and emotional state. This is true even if you use the drug only once.

MDMA is often called ecstasy. It is an illegal drug frequently taken at parties, raves or music festivals. You may believe that MDMA is a ‘safe’ drug, but it can have harmful short- and long-term effects. It is even possible to die from complications that arise from using it.

Methamphetamine is a powerful synthetic stimulant. It is illegal, highly addictive and very dangerous to your health.