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Found 10 records similar to Clinical trials and drug safety

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 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

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

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

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

Last Updated: Jun. 7, 2022
Date Published: Jun. 1, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Clinical trials, drug importation, record-keeping for clinical-trials, frequently asked questions
Federal

Consultation on guidance document: Drugs for Clinical Trials Involving Human Subjects.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  consultation, guidance document, drugs for clinical-trials, drugs involving human-subjects
Federal

Drugs intended for use in clinical trials in Canada are regulated under Division 5 of Part C of the Food and Drug Regulations. Section C.05.010(j) requires the sponsor to ensure that drugs for use in clinical trials are manufactured, handled and stored in accordance with the applicable Good Manufacturing Practices requirements referred to in Divisions 2 to 4, except for Sections C.02.019, C.02.025 and C.02.026. Sponsors of clinical trials shall ensure that imported drugs are fabricated and packaged/labelled in accordance with these requirements.

Last Updated: Jun. 7, 2022
Date Published: Nov. 16, 2020
Organization: Health Canada
Formats: HTML
Keywords:  good manufacturing practices, guidance document, drugs-used in clinical-trials, GUI-0036
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

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

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
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