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During the COVID-19 pandemic, Health Canada is working closely with domestic and international partners to anticipate and meet Canadians' health …

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: clinical trials investigational testing international engagement domestic-and-international partners collaborating and leveraging-resources regulatory-response to COVID-19 market authorizations health-product risk assessments drug shortages medical device shortages

One of Health Canada's roles is to regulate and authorize health products that improve and maintain the health and well-being …

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: access to health-products regulatory-response to COVID-19 regulate-and-authorize COVID-19 pandemic unprecedented demand urgent-need for access-to-ealth-products

The purpose of this guide is to help classify the level of severity of deviations noted as observations during inspections …

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: Classification of observations inspections clinical trials GUIDE-0043.

This section explains in detail the process of preparation of an application, its submission, screening, evaluation, authorization/rejection, submission of amendments …

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: clinical trial applications application and submission screening evaluation authorization or rejection submission of amendments post-authorization requirements

The Clinical Trial Site Information (CTSI) form is required to be submitted by clinical trial sponsors prior to initiating a …

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: clinical-trial site-information form CTSI form instructions for completing clinical-trial sponsors

This statement provides guidance to clinical trial applicants about the investigational use of marketed drugs within clinical trials in Canada.

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: clinical trial investigational Use-of-Marketed-Drugs Use-of-Marketed-Drugs in clinical-trials guidance clinical trial applicants

Health Canada answers to frequently asked questions about drug importation and record keeping for clinical trials

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: Clinical trials drug importation record-keeping for clinical-trials frequently asked questions

Clinical trials: Frequently Asked Questions.

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: Clinical trials Clinicals Trials FAQ

This manual is based on Health Canada's Guidance for Clinical Trial Sponsors: Clinical Trial Applications and other applicable guidance documents. …

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: clinical trials manual clinical trial sponsors clinical trial applications CTA facilitate successful filing

Clinical trials: Frequently Asked Questions on outline of process.

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: clinical trials frequently asked questions outline of process