Catalogue - Canadian Urban Data Catalogue (CUDC)

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Catalogue Entry: Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications

The Food and Drugs Act and the Food and Drug Regulations govern the sale and importation of drugs for use in human clinical trials in Canada. This document provides guidance on...
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Catalogue Entry: 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...
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Catalogue Entry: Final Guidance Document Data Requirements for Safety and Effectiveness of...

This guidance is intended to assist sponsors in the collection and analysis of data for Steroid Nasal products for use in the treatment of allergic rhinitis, in order to meet...
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Catalogue Entry: Clinical Trials Manual

This manual is based on Health Canada's Guidance for Clinical Trial Sponsors: Clinical Trial Applications and other applicable guidance documents. It is designed to provide...
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Catalogue Entry: Notice: Implementation of eCTD for clinical trial regulatory activities

The pilot for Clinical Trial regulatory activities in electronic Common Technical Document (eCTD) format concluded on August 31, 2019. Health Canada is pleased to announce that...
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Catalogue Entry: Notice: Preparation of Clinical Trial Regulatory Activities in the "Non-eCTD...

This Notice serves as a revision to the Release of Electronic Specifications for Clinical Trial Applications and Amendments filed in accordance with Guidance Document for...
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Catalogue Entry: Guidance Document: Preparation of Clinical Trial Applications for use of...

The purpose of this guidance is to provide information to prospective cell therapy product clinical trial sponsors to assist them in satisfying applicable Federal regulatory...
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Catalogue Entry: Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical...

To assist submission sponsors in preparing Clinical Trial Applications (CTAs) filed with Health Canada by outlining the Quality (chemistry and manufacturing) technical...
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Catalogue Entry: Request for disclosure of confidential business information (CBI)

Why we disclose confidential business information, who is eligible to request it and how to submit a request.
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Catalogue Entry: Disclosure of confidential business information

This guidance document describes how we disclose confidential business information (CBI) under paragraph 21.1(3)(c) of the Food and Drugs Act.
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Catalogue Entry: Completed requests for disclosure of confidential business information under...

The list below summarizes completed requests for Health Canada to use its authority to disclose confidential business information (CBI).
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Catalogue Entry: Update: Requirements for Tuberculosis Screening of Healthy Volunteers in...

The requirements for tuberculosis screening for certain Phase-I clinical trials in healthy volunteers.
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Catalogue Entry: Guidance for Industry: Standards for Clinical Trials in Type 2 Diabetes in Canada

Health Canada is issuing this guidance for clinical trials in type 2 diabetes to provide clarification on the interpretation of the Canadian Diabetes Association Clinical...
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Catalogue Entry: Guidance Document: Considerations for Inclusion of Women in Clinical Trials...

This document provides guidance on the study and analysis of sex differences in clinical trials of therapeutic products in order to generate evidence to advise on the optimal...
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Catalogue Entry: Notice: Release of Draft Guidance Document for Consultation: Comparative...

The purpose of this document is to provide sponsors of new drug submissions and abbreviated new drug submissions with the information necessary to comply with Sections...
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Catalogue Entry: The Canadian Laboratory Information Network (CANLINE)

CANLINE is the Food Directorate's (Health Canada) searchable database for chemical, nutritional, and microbiological laboratory surveillance data. This includes data from...
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Catalogue Entry: Health product advertising incidents related to COVID-19: COVID-19...

Learn more about drugs and vaccines being developed or authorized for COVID-19.
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Catalogue Entry: Interim order regulating certain UV radiation-emitting and ozone-generating...

The Interim Order Respecting Ultraviolet Radiation-emitting Devices and Ozone-generating Devices under the Pest Control Products Act was made on June 7, 2021. This interim order...
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Catalogue Entry: Medical Devices Action Plan: Progress report

This update shows you the progress we have made on the Medical Devices Action Plan (MDAP), and points to areas where we will continue to deliver results to Canadians.
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Catalogue Entry: Priority strategies to optimize testing and quarantine at Canada’s borders

In November 2020, the Minister of Health established the COVID-19 Testing and Screening Expert Advisory Panel. The Panel provides evidence-informed advice to the federal...
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2,942 catalogue entries found