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Found 10 records similar to Guidance Document - Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines Drugs Used in Clinical Trials (GUI-0036)

Federal

The Clinical Trial Site Information (CTSI) form is required to be submitted by clinical trial sponsors prior to initiating a protocol or implementing subsequent amendment(s) at the clinical trial site for trials that are subject to Division 5 of Part C of the Food and Drug Regulations or the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.

Last Updated: Jun. 7, 2022
Date Published: Jan. 18, 2022
Organization: Health Canada
Formats: HTML
Keywords:  clinical-trial site-information form, CTSI form, instructions for completing, clinical-trial sponsors
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

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

This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in humans to understand and comply with Part C, Division 5 of the Food and Drug Regulations (the Regulations).

Last Updated: May 4, 2021
Date Published: Aug. 20, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Guidance, Part C, Division 5, Food and Drug Regulations, Drugs for Clinical Trials, Clinical Trials Involving Human Subjects, GUI-0100
Federal

This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in humans to understand and comply with Part C, Division 5 of the Food and Drug Regulations (the Regulations).

Last Updated: May 4, 2021
Date Published: Aug. 21, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Guidance, Part C, Division 5, Food and Drug Regulations, Drugs for Clinical Trials, Clinical Trials Involving Human Subjects, GUI-0101
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

Sponsors of COVID-19-related drug and vaccine clinical trials can choose between 2 different processes: existing process outlined in the Food and Drug Regulations or process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

Last Updated: Jun. 30, 2021
Date Published: May 1, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, clinical trials, drugs, vaccine, apply for a trial authorization, Medical Devices Regulations, interim order for clinical trials for drug and vaccine related to COVID-19
Federal

Guidance documents for management of drugs for clinical trials involving human subjects. The sponsor must ensure that the clinical trial is conducted in accordance with the requirements of the protocol, which has been authorized by Health Canada and approved by REB(s).

Last Updated: Apr. 7, 2020
Date Published: Mar. 23, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19 pandemic, drugs for clinical trials involving human subjects, Research Ethics Board (REB).
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

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 Practice Guidelines (CDA-CPG)Footnote1 in relation to clinical trial applications under Part C, Division 5 of the Food and Drug Regulations.

Last Updated: Jun. 2, 2021
Date Published: Sep. 4, 2007
Organization: Health Canada
Formats: HTML
Keywords:  guidance for industry, standards, clinical trials in type 2 diabetes, Canadian Diabetes Association Clinical Practice Guidelines, CDA-CPG, Food and drug Regulations
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