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Drug shortages in Canada: Regulations and guidance
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-... -
Service Standard for the Right to Sell Drugs under the Food and Drug Regulations
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,... -
Methanesulfonamide,...
Questions and answers regarding the uses of Methanesulfonamide, N-[2-[(2,6-dicyano-4-methylphenyl)azo]-5-(dipropylamino)phenyl] (DADM) and actions taken to protect the public... -
Preparation of the Quality Information for Drug Submissions in the CTD...
This document is intended to provide Industry with guidance for the preparation of drug submissions for Biotechnological/ Biological Products. It is structured using the... -
Notice: Improving access to medical devices information
Health Canada is initiating the transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), in order to improve the... -
Post-Notice of Compliance (NOC) Changes – Quality Guidance
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... -
Summary Safety Review - Atypical antipsychotics - Assessing the potential...
Health Canada reviewed the potential risk of DRESS with the use of atypical antipsychotics, following the manufacturers’ voluntary update of the product safety information for... -
Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document
This information will help sponsors comply with the Food and Drug Regulations (Regulations), with respect to comparative studies, with emphasis on in vivo comparative... -
Guidelines for Canadian Drinking Water Quality: Guideline Technical Document – Barium
Naturally occurring barium can be found in most types of rocks and can enter surface and groundwater by leaching and eroding from sedimentary rocks. A maximum acceptable... -
Summary Safety Review - Phenylephrine and acetaminophen - Drug-drug interaction
Health Canada initiated a safety review following a report by the European Medicines Agency about the potential drug-drug interaction between phenylephrine and acetaminophen.... -
Consumer Product Enforcement Summary Report: Standards Project 2017-2018:...
The purpose of this Standards project was to sample clothing storage units over 30 inches (762 mm) in height and test them to the performance criteria of a consensus-based... -
Novel Food Information - High Pressure Processing (HPP)-Treated Egg Salad,...
Health Canada has notified Burnbrae Farms Ltd., that it has no objection to the food use of High Pressure Processing (HPP)-treated egg salad, egg dips, and egg spreads. The... -
Opioid Pain Medications Frequently Asked Questions
2009 article from Health Canada and the Public Health Agency of Canada regarding the safe use of Opioid drugs -
Consumer Product Enforcement Summary Report - Cyclical Enforcement Project...
The Consumer Product Safety Program (CPSP) of Health Canada administers and enforces the Canada Consumer Product Safety Act (CCPSA) and its regulations by conducting... -
Diazenedicarboxamide
This substance was identified for action under the Chemicals Management Plan (CMP). -
Notice - Revision to the Post-Notice of Compliance (NOC) Changes - Notices...
Revisions to change #2 (Appendix 1) have been made to the Guidance Document: Post-Notice of Compliance (NOC) Changes: Quality. The Level III changes form has been revised to... -
Guidance on Drug Establishment Licences (GUI-0002)
This guide is for companies in the drug manufacturing industry. It will help to facilitate understanding and compliance with Part C, Division 1A of the Food and Drug Regulations... -
Compliance Verification Project 2022-2023: Liquid-filled Teethers
The purpose of this Compliance Verification (CV) project was to verify industry’s compliance of liquid-filled teethers with the requirements of Schedule 2, Item 4 of the CCPSA. -
Guidelines for Canadian Drinking Water Quality: Guideline Technical Document – pH
Health Canada recently completed its review of the considerations associated with the pH of drinking water. Based on this review, the operational guideline for the pH of... -
Proposed Registration Decision PRD2021-04, Pyridate and Tough 600 EC Herbicide
This Summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2021-04, Pyridate and Tough 600 EC Herbicide provides...