Health Canada

The Guidance Document: Management of Drug Submissions and Applications (MDSG) gives sponsors and Health Canada staff operational direction and guidance when managing information submitted in accordance with the Food and Drugs Act and its Regulations.

Good Laboratory Practice (GLP) covers the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, archived and reported. It is intended to promote the quality and validity of test data and improve the...

A non-prescription drug Category IV Monograph outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active ingredients and combinations thereof. Category IV Monographs are developed for drugs that have a well characterized...

The purpose of this document is to provide guidance to sponsors to facilitate compliance with the labelling requirements pursuant to sections 3, 9, and 10 of the Food and Drugs Act as well as related provisions of the Food and Drug Regulations and the Controlled Drugs and Substances Act.

The safe use of non-prescription drugs depends on consumers being able to identify the desired product and also being able to understand and act upon the information presented. The label and package are the first points of interaction between a health product and a consumer or healthcare...

A nonprescription drug labelling standard outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active ingredients and combinations thereof. Labelling standards are developed for drugs that have a well characterized safety...

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 intended to provide basic considerations for the detection, assessment, mitigation and reporting requirements of...

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 (WHI) trial and the Women's Health Initiative Memory Study (WHIMS). This document is intended to help the pharmaceutical...

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 standardized format so that consumers can find important product information quickly and easily.

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 includes antiseptic products whether they are regulated under the Food and Drug Regulations (FDR) or the Natural...

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 concentrations and combinations are restricted to those specified in this monograph. Full justification supported with...

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 to be reviewed in the submissions. It expands on the design of clinical trials when patients with active duodenal...

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 industry and health care professionals understand how to comply with regulations. They also provide guidance to Health...

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

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 indicates that the evaluation of the drug determined that it met the relevant requirements of the Food and Drugs Act and its...

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 and Drugs Act) in Canada Gazette, Part II. The objective of this regulatory amendment is to apply to Schedule C Drugs...

(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 filed pursuant to Division 8 of the Food and Drug Regulations is regarded as an application for a DIN. When a product is...

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 disinfectants and sterilants on reusable semi-critical and critical medical devices, which are regulated as medical devices...

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

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 for undisclosed test or other data necessary to determine the safety and effectiveness of a pharmaceutical product which...