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Guidance Document - Pharmaceutical Development ICH Topic Q8(R2)
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.... -
Notice for Hospitals: Mandatory Reporting Requirement during the COVID-19 Pandemic
"Health Canada appreciates the critical role health professionals in Canada play in identifying, reporting and managing potential cases of COVID-19 and recognizes the pressures... -
Proposed Registration Decision PRD2021-03, Fluazaindolizine and Salibro Nematicide
This Summary describes the key points of the evaluation, while the Science evaluation of Proposed Registration Decision PRD2021-03, Fluazaindolizine and Salibro Nematicide... -
Subsection 56(1) Class Exemption for the Person in Charge of a Hospital...
Subsection 56(1) Class Exemption for the Person in Charge of a Hospital and/or a Pharmacist who Supplies Controlled Substances to a Community Health Facility -
ACCESS Consortium: Points to consider for strain changes in authorised...
This Points to Consider document lays out a regulatory approach for updating authorised coronavirus vaccines should mutations at any time make them less efficacious due to... -
Laboratory Procedures for the Microbiological Analysis of Foods
Volume 3 - The Compendium of Analytical Methods -
Draft guidance on management of rolling reviews for drug submissions:...
To apply for rolling review status for a forthcoming new drug submission (NDS) or supplement to a new drug submission (SNDS), sponsors must provide a Rolling Review Application... -
Consumer Product Enforcement Summary Report - Cyclical Enforcement Project...
The purpose of this Cyclical Enforcement (CE) project was to verify industry’s compliance of cosmetic wipes with specific requirements of the FDA and the Cosmetic Regulations. -
Guidance Document - Comparative Bioavailability Standards: Formulations Used...
To ensure that sponsors of new drug submissions have the information necessary to comply with Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3) of the Food and Drug... -
Guidance Document: Regulatory requirements for Drug Identification Numbers...
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... -
Improving Cooking and Food Preparation Skills: A Synthesis of the Evidence...
The purpose of this paper is to synthesize the state of knowledge and research gaps related to cooking and food preparation skills among children and families. The paper... -
Canada-New Brunswick Bilateral Agreement for Pan-Canadian Virtual Care...
Canada and New Brunswick agree that immediate action and collaboration was and continues to be needed among governments to expand virtual care services to support improved... -
Substance Use Spectrum
People use substances, such as controlled and illegal drugs, cannabis, tobacco/nicotine and alcohol for different reasons, including: medical purposes, personal enjoyment,... -
Clinical trials multiple subjects Frequently Asked Questions
Clinical trials: Frequently Asked Questions. -
Nutrition Policy Reports
Lead page to Health Canada reports, discussion papers and articles related to research on nutritional health -
Interim guide on isopropyl alcohol for use in alcohol-based hand sanitizers...
As outlined in the Quality of Natural Health Products Guide, isopropyl alcohol (IPA) used in the production of hand sanitizers should meet identity and purity criteria. -
Clinical trials and special access programs
Special access programs. -
Clostridium botulinum Challenge Testing of Ready-to-Eat Foods
The purpose of this document is to recommend experimental design for challenge testing studies to determine if Clostridium botulinum can grow and produce toxin in ready-to-eat... -
Guidelines for Canadian Drinking Water Quality: Guideline Technical Document...
This guideline technical document was prepared in collaboration with the Federal-Provincial-Territorial Committee on Drinking Water and is based on assessments of bromoxynil...