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Found 10 records similar to Order to extend review period for clinical trial applications and amendments: Notice

Federal

As set out in paragraph C.05.010(b) of the Food and Drug Regulations (FDR), clinical trials must follow certain requirements of the protocol. Health Canada authorizes this protocol and the Research Ethics Board approves it. During the pandemic, there may be more deviations from the established protocol.

Last Updated: Jun. 7, 2022
Date Published: Mar. 2, 2022
Organization: Health Canada
Formats: HTML
Keywords:  Management of clinical-trials, clinical-trials during COVID-19, clinical-trials during pandemic, notice to clinical-trial-sponsors
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

Food and Drug Regulations-Amendment (Schedule No.1024) Clinical Trial Framework

Last Updated: Jun. 7, 2022
Date Published: May 18, 2018
Organization: Health Canada
Formats: HTML
Keywords:  food-and-drug regulations, regulations-amendment, Schedule No.1024, 1024 clinical-trials, clinical-trial framework
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

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

All Clinical Trial Applications (CTAs) and Clinical Trial Application Amendments (CTA-As) are subject to a 30-day default review period from the date of receipt of a complete application in Health Canada.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  review of application, clinical-trial aApplications, CTAs, clinical-trial application amendments, CTA-As, default review period
Federal

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.

Last Updated: Jun. 7, 2022
Date Published: Apr. 6, 2022
Organization: Health Canada
Formats: HTML
Keywords:  clinical-trials, clinical-trials for COVID-19-medical-devices, list of authorized-clinical-trials
Federal

Provides answers to frequently asked questions about Health Canada filing requirements for clinical trials

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  clinical trials, frequently asked questions, filing of clinical-trials, filing-requirements for clinical-trials
Federal

Clinical trials can be an important treatment option. However, like all drugs, the drugs used in clinical trials have possible benefits and risks. There is often less information about the safety and efficacy of a drug being studied in a clinical trial than for an authorized drug.

Last Updated: Jun. 7, 2022
Date Published: May 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  clinical-trials, clinical-trials and drug-safety, drugs used-in clinical-trials, possible benefits-and-risks, dug safety-and-efficacy, authorized drug
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
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