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Found 10 records similar to Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals

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
Federal

The following section provides the requirements for a CTA involving the use of pharmaceutical, biological, and radiopharmaceutical drugs. The requirements are the same for these drug products with a few exceptions.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  clinical trial applications, CTAs, CTA involving pharmaceutical, CTA involving biological, CTA involving radiopharmaceutical-drugs
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

The requirements for tuberculosis screening for certain Phase-I clinical trials in healthy volunteers.

Last Updated: Jun. 2, 2021
Date Published: Dec. 18, 2007
Organization: Health Canada
Formats: HTML
Keywords:  tuberculosis screening, requirements for tuberculosis screening, healthy volunteers, Phase I clinical trials, immunosuppressant drugs, drugs with immunosuppressant properties
Federal

On April 1, 2006, the Canadian Forces Members and Veterans Re-establishment and Compensation Act (the New Veterans Charter) came into force. The New Veterans Charter (NVC) was designed to give Canadian Forces (CF) Veterans and their families access to services and programs that would meet their individual needs. The suite of programs includes: rehabilitation; financial benefits; group health insurance; career transition services; disability award; and support to families. The evaluation was conducted from April 1, 2009 until October 29, 2010 and consisted of three phases.

Last Updated: Feb. 24, 2022
Date Published: Feb. 28, 2011
Organization: Veterans Affairs Canada
Formats: PDF HTML
Keywords:  Veterans Affairs Canada, Internal auditing, Evaluation, Veterans, New Veterans Charter, NVC
Federal

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 the regulatory obligations pursuant to Part C, Division 5 of the Regulations, Drugs for Clinical Trials Involving Human Subjects.

Last Updated: Jun. 1, 2021
Date Published: Jun. 29, 2016
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, clinical trial, clinical trial applications, Food and Drugs Act, Food and Drug Regulations, human clinical trials, regulatory obligations, du+H36gs for clinical trials involving human subjects
Federal

The Government of Canada plans to assess and manage, where appropriate, the potential health and ecological risks associated with approximately 1,550 substances included in the third phase of the Chemicals Management Plan (CMP).

Last Updated: Aug. 30, 2022
Date Published: Dec. 10, 2021
Organization: Health Canada
Formats: HTML
Keywords:  third-phase, chemicals management plan, health-and-ecological risks, substances
Federal

The New Veterans Charter (NVC) represents the most sweeping change to Veterans’ benefits and services in the past 60 years. The NVC shifts the focus from one of disability to one of wellness and responds to Canada’s commitment to injured Canadian Forces members and Veterans. The suite of services and benefits available under the NVC include a lump-sum disability award, rehabilitation, financial benefits, health benefits, and career transition services. This is a three-phased comprehensive evaluation being conducted from April 2009 to December 2010.

Last Updated: Feb. 24, 2022
Date Published: Aug. 31, 2010
Organization: Veterans Affairs Canada
Formats: PDF HTML
Keywords:  Veterans Affairs Canada, VAC, Internal audit, Evaluation, New Veterans Charter, NVC, Veterans
Federal

Guidance document provides applicants seeking authorization to conduct COVID-19 drug clinical trials specifically around the applications guidelines and process.

Last Updated: May 28, 2021
Date Published: Apr. 28, 2021
Organization: Health Canada
Formats: HTML
Keywords:  guidance, document, Interim Order, coronavirus, COVID-19, clinical trial, drug, regulations, clinical trial phases
Federal

This section explains in detail the process of preparation of an application, its submission, screening, evaluation, authorization/rejection, submission of amendments and post-authorization requirements.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  clinical trial applications, application and submission, screening, evaluation, authorization or rejection, submission of amendments, post-authorization requirements
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