Health Canada

This document encompasses all in-house research including contracted social, physical and natural science activities toward generation of new knowledge conducted within Health Canada's Healthy Environments and Consumer Safety Branch (HECSB) in 2019-2020.

Evidence of Good Manufacturing Practices (GMP) for drug submissions. The goal of this revision is to better align the drug submission screening and review process with the Drug Establishment Licence (DEL) process. This should allow sponsors to make timely drug submissions while still providing...

This guidance document is specific to the "tamper-resistance" feature of controlled-release opioid products. It is intended for the pre-market review of drug submissions when sponsors seek to obtain approval for controlled-release opioid drug formulations with tamper-resistant properties and wish...

This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. These new drugs may include pharmaceuticals, biologics, and radiopharmaceuticals for human use and pharmaceutical and certain...

After a new drug as defined in section C.08.001 of the Food and Drug Regulations has been granted a Notice of Compliance (NOC), it is not uncommon for sponsors to make changes to the drug. A post-NOC change is any change that is made to a new drug that has received a NOC pursuant to section...

This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. These new drugs may include pharmaceuticals, biologics, and radiopharmaceuticals for human use, including those submissions for...

A post-NOC change is any change that is made to a new drug that has received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. Many of these changes may be made to improve the quality of the drug product or the efficiency of the manufacturing process, or they could be made for...

This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to Section C.08.004 of the Food and Drug Regulations. This may include pharmaceuticals, biologics and radiopharmaceuticals for human use and pharmaceutical, radiopharmaceutical and...

Health Canada is publishing this document to be transparent about the principles and factors that it considers when deciding whether a drug would be best sold as a prescription or nonprescription product. This document is also designed to help the public, industry and healthcare professionals,...

This guidance aims to articulate Health Canada's expectations and generate a level of consistency regarding the interpretation of the Priority Review of Drug Submissions policy and the filing of a Priority Review request. Additional clarification of the process by which the Priority Review...

The purpose of this guidance document is to assist sponsors in developing product monographs with acceptable format and content. Health Canada reviews the product monograph as part of the drug review process, as it forms an integral part of a new drug submission. A product monograph is intended...

The Periodic Benefit-Risk Evaluation Report (PBRER) described in this Guideline is intended to be a common standard for periodic benefit-risk evaluation reporting on marketed products (including approved drugs that are under further study) among the International Conference on Harmonisation (ICH)...

Section C.01.018 of Division 1 of the Food and Drug Regulations requires the Market Authorization Holder (MAH) to analyze adverse drug reaction data and prepare an annual summary report. Annual summary reports are to be submitted when requested by Health Canada. In addition, Section C.01.018(4)...

The Health Product Vigilance Framework is being developed to strengthen and modernize health product vigilance (PV) practices in Canada. Aligned with the Federal Regulatory Post-Market Surveillance Strategy, this framework will optimize resources by focusing on higher risk products through...

To provide market authorization holders direction on the process to be followed and information to be submitted to Health Canada regarding the potential for a proposed name to be misleading or confused with another product authorized for use in Canada with the aim of preventing medication errors.

The purpose of this Notice is to notify stakeholders that Health Canada has made changes to the opioid patient information handout entitled “Opioid Medicines – Information for Patients and Families”. Canada's Food and Drug Regulations were recently amended to require that a warning sticker and...

Health Canada has identified the need for patients to receive clear information about the safe use of opioids and the risks associated with their use. As such, requirements have been added, under the Food and Drug Regulations, for a warning sticker and patient information handout to be provided...

This guidance is intended to harmonize and to update the prescribing information for nonsteroidal anti-inflammatory drugs () indicated for controlling pain and inflammation associated with rheumatic diseases and other less severe conditions. Each Product Monograph is expected to contain...

This document provides information for industry on how Health Canada's Health Products and Food Branch interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) for prescription products and those administered...

This document provides information for industry on how Health Canada's Health Products and Food Branch interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) for non-prescription (Over-the-Counter, OTC) drug...