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Found 10 records similar to Review of your Application

Federal

Depending on the type of clinical trial, sponsors may be required to file a Clinical Trial Application (CTA) for human drug clinical trials. Instances where a CTA must be filed are summarized in the chart below.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2018
Organization: Health Canada
Formats: HTML
Keywords:  clinical-trial-application, clinical-trial-application process, clinical-trial, clinical-trial sponsors, file a clinical-trial-application, CTA, human drug clinical-trials
Federal

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 tools and relevant links in order to facilitate the successful filing of a Clinical Trial Application (CTA) to Health Canada.

Last Updated: Jun. 7, 2022
Date Published: May 9, 2007
Organization: Health Canada
Formats: HTML
Keywords:  clinical trials manual, clinical trial sponsors, clinical trial applications, CTA, facilitate successful filing
Federal

This Notice serves to inform clinical trial sponsors that Health Canada will publish information about all clinical trial applications (CTAs) authorized as of April 1, 2013, for the study of drugs in patients.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  publication of information, information about clinical-trial-applications, clinical trial applications, CTAs, clinical trial sponsors
Federal

New Guidance for Clinical Trial Sponsors: Clinical Trial Applications

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  post-authorization requirements, clinical-trial sponsors, clinical-trial applications
Federal

The pre-CTA consultation meeting provides an opportunity for the sponsor to present relevant data, discuss concerns and resolve issues regarding drug development. It also gives Health Canada an opportunity to provide guidance on the acceptability of the proposed trial(s).

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  pre-clinical trial application, CTA consultation meeting, clinical-trial sponsors, clinical-trial applications
Federal

To assist submission sponsors in preparing Clinical Trial Applications (CTAs) filed with Health Canada by outlining the Quality (chemistry and manufacturing) technical requirements for CTAs pursuant to Division C.05 of the Food and Drug Regulations.

Last Updated: Jun. 2, 2021
Date Published: Mar. 12, 2009
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, quality technical requirements, chemistry and manufacturing, clinical trial applications, CTAs, Pharmaceuticals
Federal

This Ministerial Order (MO) will give Health Canada an additional 15 days to review all clinical trial applications and amendments submitted under Division 5 of the Food and Drug Regulations.

Last Updated: Jun. 7, 2022
Date Published: Sep. 20, 2021
Organization: Health Canada
Formats: HTML
Keywords:  clinical trial, clinical trial applications-amendments, Ministerial Order, clinical-trial review period, extend review period
Federal

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 tools and relevant links in order to facilitate the successful filing of a Clinical Trial Application (CTA) to Health Canada.

Last Updated: Jun. 2, 2021
Date Published: May 9, 2007
Organization: Health Canada
Formats: HTML
Keywords:  clinical trials manual, human clinical trials, regulatory obligations, dugs for clinical trials involving human subjects
Federal

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

Last Updated: Jun. 7, 2022
Date Published: Apr. 26, 2021
Organization: Health Canada
Formats: HTML
Keywords:  clinical trial, investigational Use-of-Marketed-Drugs, Use-of-Marketed-Drugs in clinical-trials, guidance, clinical trial applicants
Federal

CTA-As are applications in which a sponsor proposes information to support changes to a previously authorized application

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Clinical Trial Application- Amendments, CTA-As, changes to authorized-application, clinical amendments
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