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Found 10 records similar to Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100) - Summary

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

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

Canada aims to reduce the risks to participants who enroll in clinical trials. Learn about clinical trial inspections and how we conduct them.

Last Updated: Apr. 28, 2021
Date Published: Oct. 28, 2016
Organization: Health Canada
Formats: HTML
Keywords:  clinical trials, inspections of clinical trials, human drugs clinical trials
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

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

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

For the purpose of this guidance document, Health Canada has determined that certain submissions and applications involving human or disinfectants drugs may be submitted for administrative processing as they do not contain scientific data.

Last Updated: Sep. 17, 2020
Date Published: Apr. 1, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Administrative process of submission and application, submission and application of human and disinfectant drugs.
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

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
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