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Open Data Portal Catalogue Dataset
Found 38944 records

Each year CCOHS prepares an Annual Report (of the Council) detailing its goals and accomplishments for the year. This report also includes the audited CCOHS Financial Statements.

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Canadian Centre for Occupational Health and Safety
Formats: PDF
Keywords: Annual Report

In agreeing to apply the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Canada has committed to provide up to two years of sui generis (of its own kind) protection for new pharmaceutical products protected by an eligible patent, from the expiry of the patent. Canada has implemented this commitment by introducing Certificates of Supplementary Protection (CSPs) for medicinal ingredients, applicable for Canadian pharmaceuticals, biologics and veterinary drugs.

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document certificates of supplementary-protection new pharmaceutical products eligible patent pharmaceuticals biologics veterinary drugs

This guidance was developed by the appropriate ICH Expert Working Group and was subject to consultation by the regulatory parties, in accordance with the ICH Process. ICH E10 has been implemented by the regulatory bodies of the United States, European Union, Japan, Switzerland and Australia.

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document E10 choice of control-group clinical trials

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. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan and USA.

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document ethnic factors acceptability-of foreign clinical data ICH Topic E5(R1)

The purpose of this guidance document is to provide manufacturers of Class IV Human Immunodeficiency Virus (HIV) rapid diagnostic tests (RDTs) intended to be used at the point of care (POC) and/or for self-testing (home testing) with specific recommendations on: (1) the analytical and clinical data, and (2) device labelling, required to support a medical device licence application.

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document guidance for manufacturers human immunodeficiency virus HIV rapid diagnostic tests RDTs point of care self-testing

The Privacy Act (the Act) provides Canadian citizens and permanent residents with the right of access to and correction of personal information about themselves that is under the control of a government institution. The Act also provides the legal framework for the collection, retention, use, disclosure, disposition and validation of the accuracy of personal information in the administration of programs and activities by government institutions subject to the Act. This report has been prepared and tabled in Parliament in accordance with section 72 of the Act. It covers the period from April 1, 2022, to March 31, 2023, for the …

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Impact Assessment Agency of Canada
Formats: HTML
Keywords: ATIP Privacy Act Annual Report

This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state. It is not intended to apply to new drug substances used during the clinical research stage of development.

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document ICH technical requirements pharmaceuticals for human-use impurities in new-drug-substances ICH Topic Q3A(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. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan and USA.

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document pharmaceutical development ICH Topic Q8(R2)

This guidance is intended to assist sponsors in the collection and analysis of comparative clinical data for Inhaled Corticosteroid (ICS) products used for the treatment of asthma that contain the same medicinal ingredient and have the same conditions of use as the Canadian Reference Product (CRP) in order to meet the safety and effectiveness requirements under C.08 of the Food and Drug Regulations [Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3)].

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document data requirements safety-and-effectiveness of subsequent entry inhaled Corticosteroid products treatment of asthma

Loss of control and collision with water, True North Airways Inc., de Havilland DHC-3 Otter, C-FDDX, Pluto Lake, Quebec, 12 October 2022

Last Updated: Dec 2, 2023
Date Published: Dec 1, 2023
Publisher: Transportation Safety Board of Canada
Formats: HTML
Keywords: safety investigation report