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Structure and Content of Clinical Study Reports ICH Topic E3: Guidance for industry
The objective of this guidance document is to allow the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions. The... -
Nutrition and Healthy Eating
Food nourishes the body and gives us energy to get through each day. Healthy eating is fundamental to good health and is a key element in healthy human development, from the... -
How Health Canada inspects medical device establishments: Overview
These guidelines describe how Health Canada inspects licensed medical device establishments (companies). They describe the inspection process and explain how inspectors assess... -
Notice: Prescription Drug List (PDL): Diclofenac
The purpose of this Notice of Amendment is to notify that Health Canada has revised the listing for diclofenac on the Prescription Drug List (PDL). Only the Human part of the... -
Guidelines for Canadian Drinking Water Quality: Guideline Technical Document...
Canadians can be exposed to carbon tetrachloride through its presence in air and drinking water. In addition, certain segments of the population may be exposed through the use... -
Radon action guide for provinces and territories: Overview
This Radon Action Guide provides many steps provinces and territories can take to reduce radon exposure. Radon affects all types of buildings, and radon action affects many... -
Guidance document for consultation: Recreational water quality: Physical,...
This guideline technical document evaluated the available information on physical, chemical and aesthetic characteristics of recreational waters with the intent of recommending... -
Declare identity and patent status of pharmaceutical product under Canada's...
The pharmaceutical company must complete and submit to the Commissioner of Patents one of the forms listed below. The company should choose the form that corresponds to the... -
Real-time Environmental Radioactivity Monitoring in Canada
Terrestrial gamma dose rates, reported as ambient dose equivalent in the unit nSv/hr, are presented for the past ninety days to present. Data is measured in real-time, typically... -
Optimizing the Use of Real World Evidence to Inform Regulatory Decision-Making
Health Canada’s Evolving Approach to Leveraging Real World Evidence (RWE) for Drug Regulatory Decisions. -
Novel Food Information: Sugarcane CTC91087-6
Health Canada has notified Centro de Tecnologia Canavieira that it has no objection to the food use of raw and refined sugar derived from sugarcane event CTC91087-6. The... -
Proposed Re-evaluation Decision PRVD2021-09, Mustard Seed Powder (Brassica...
This document (Proposed Re-evaluation Decision PRVD2021-09, Mustard Seed Powder (Brassica hirta) and Sodium Alpha-olefin Sulfonate and Their Associated End-use Products)... -
Notice – Release of ICH S5(R3): Detection of Toxicity to Reproduction for...
Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance... -
Consumer Product Enforcement Summary Report – Cyclical Enforcement Project:...
The purpose of this Cyclical Enforcement (CE) project was to verify compliance of matches which are subject to the Matches Regulations. -
Guidelines for Canadian Drinking Water Quality: Guideline Technical Document...
This guideline technical document provides the scientific information used to update the guideline for bromate in drinking water. It reviews and assesses all identified health... -
Imfinzi – Notice of Compliance with Conditions - Qualifying Notice
Notice of Compliance with Conditions - Qualifying Notice. -
Proposed Registration Decision PRD2022-02, Sheep Fat, Trico and Trico Garden
This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2022-02, Sheep Fat, Trico and Trico Garden provides... -
Hydroquinone
Questions et réponses concernant les utilisations de l'hydroquinone et les mesures prises pour protéger le public et l'environnement. -
Summary: Guidance Document - Post-Notice of Compliance (NOC) Changes:...
The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs (ie. changes to a drug that have... -
Interim Order respecting the prevention and alleviation of shortages of...
This interim order (IO) provides more tools for urgently addressing drug shortages related to COVID-19.