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The medicine regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom (Access Consortium) have discussed the regulatory evidence requirements for...

Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed here.

The list below includes all applications received by Health Canada for drugs and vaccines used for the COVID-19 pandemic. This list includes applications received under the...

Two of the vaccines approved for use in Canada are viral vector-based vaccines: AstraZeneca and Janssen. These types of vaccines use a harmless virus (in this case, the...

Two of the vaccines approved for use in Canada are messenger RNA vaccines (called mRNA vaccines): Pfizer and Moderna. mRNA vaccines are a new type of vaccine. They don't use...

Canada’s obligations under the North American Free Trade Agreement and the Agreement on Trade-Related Aspects of Intellectual Property Rights require the granting of protection...

This guidance document outlines the information considered necessary to support the safety and effectiveness of contact lens disinfectants, which are regulated as medical...

This guidance document outlines the information considered necessary to support the safety and effectiveness of chemical products that are represented for use as high-level...

(DIN) has been assigned for that drug and the assignment of the number has not been cancelled pursuant to section C.01.014.6. In the case of a new drug, a new drug submission...

On December 13, 2017, Health Canada published the Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs in Dosage Form Listed in Schedule C to the Food...

When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the manufacturer and printed on the package labels. A DIN...

The purpose of this document is to assist stakeholders with the interpretation of legislation and regulatory requirements about distributing samples of prescription drugs, non-...

These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. Guidance documents like this one are meant to help...

The purpose of this document is to suggest elements for consideration when designing clinical trials dealing with eradication of H. pylori in GI diseases and to outline elements...

This monograph applies to products in the form of liquid concentrate that are intended to be used for acute and chronic haemodialysis. The medicinal ingredients, their...

An antiseptic product is considered to be one that inactivates, reduces, prevents or arrests growth of microorganisms with the inherent intent to mitigate or prevent disease....

This proposed guidance will assist manufacturers, packagers, and distributors of non-prescription drugs in developing plain language labelling content for a Facts Table in a...

Health Canada initiated a Hormone Replacement Therapy (HRT) class labelling project in light of new safety information derived from the results of the Women's Health Initiative...

Hepatotoxicity caused by exposure to a drug or non-infectious agent is injury or damage to the liver that may be associated with impaired liver function. This document is...

A nonprescription drug labelling standard outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active...