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ICH E8(R1): General Considerations for Clinical Studies
This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process.... -
Guidelines for Canadian Drinking Water Quality: Guideline Technical Document...
Guideline Technical Document - Enteric Viruses equation-4 -
Novel Food Information - High Pressure Processing (HPP)-Treated Fruit and...
Health Canada has notified Sunflower Organics Inc. (operated as Drinkme Beverage Co.), that it has no objection to the food use of High Pressure Processing (HPP)-treated fruit... -
Guidelines for Canadian Recreational Water Quality – Third Edition
The primary goal of the Guidelines for Canadian Recreational Water Quality is the protection of public health and safety. This document provides guidance on the factors that can... -
Consultation: Guidelines for Canadian Recreational Water Quality:...
Purpose of consultation This guideline technical document evaluated the available information on managing risks in recreational areas with the intent of updating/recommending a... -
Request for data: Partially hydrogenated oils in the Canadian food supply
The information being solicited by this call for data pertains to PHOs used as food ingredients. -
Concentration of Contaminants and Other Chemicals in Food Composites
The Canadian Total Diet Study (TDS) is a food surveillance program that monitors the concentrations of chemical contaminants in foods that are typically consumed by Canadians -
Guidance Document: Reconsideration of Decisions Issued for Human Drug...
When Health Canada issues certain negative decisions related to the submission review process for a human drug, including hard-surface disinfectants, or a natural health... -
Guidelines for the Safety Assessment of Novel Foods
These Guidelines are intended to assist the petitioner in preparing a novel food notification and to ensure that the information is sufficient to for a safety assessment. -
Notice: Prescription Drug List (PDL): Hyoscine butylbromide
The purpose of this Notice of Amendment is to notify that Health Canada will switch injectable Hyoscine butylbromide to prescription status from ethical status for human use by... -
Annex 7 to the Good manufacturing practices guide for drug products -...
This document is an annex to the Good manufacturing practices guide for drug products (GUI-0001). These guides will help you understand and comply with Part C, Division 2 of the... -
Health Canada’s regulatory response to COVID-19: Access to health products
One of Health Canada's roles is to regulate and authorize health products that improve and maintain the health and well-being of Canadians. The COVID-19 pandemic has created an... -
Libtayo - Notice of Compliance with Conditions - Qualifying Notice
Notice of Compliance with Conditions - Qualifying Notice -
Reduce your risk: Choose legal cannabis
While cannabis is legal in Canada, illegal products are still being sold and consumed in Canada. Learn to recognize the differences between legal and illegal cannabis, and find... -
Water Talk – Cadmium in drinking water
Health Canada has developed a guideline value for cadmium in drinking water to protect the health of Canadians. Learn about the health effects of cadmium and how to reduce your... -
Canadian recreational water quality guidelines - Indicators of fecal...
Epidemiological studies investigating the association between GI and bacterial fecal indicators during primary contact recreational activities in fresh and marine waters... -
The advertising preclearance system
To ensure that advertising material meets Canadian regulatory standards for advertisements for drugs and medical devices, advertising preclearance agencies (APAs) provide review... -
Poly(amines) Group - information sheet
As a result of the screening assessment, these 9 substances are considered to have low potential for risk to human health and the environment. -
Notice of danger to human health or safety and risk mitigation for USB chargers
Health Canada has assessed the hazards associated with the use of USB chargers. These products may pose an electric shock, burn, or fire hazard. -
Guidance Document - Guide for the Preparation of Applications for...
This Guidance document provides information on the interpretation and application of sections C.03.301 to C.03.320 of the Food and Drug Regulations (the Regulations) applicable...
Vous pouvez également accéder à ce catalogue en utilisant l'API (cf. Documentation de l'API).