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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

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

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

Health Canada is issuing this notice to clinical trial sponsors to clarify key obligations under the Food and Drug Regulations (FDR) for various types of cannabis-based clinical research.

Last Updated: Jun. 1, 2021
Date Published: Feb. 5, 2021
Organization: Health Canada
Formats: HTML
Keywords:  notice to stakeholders, clarification of requirements, Food and Drug Regulations, clinical trial, clinical research, cannabis
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 guide is for companies in the drug manufacturing industry. It will help to facilitate understanding and compliance with Part C, Division 1A of the Food and Drug Regulations (FDR) with regards to drug establishment licence (DEL) requirements.

Last Updated: Apr. 26, 2021
Date Published: Dec. 21, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Guidance, drug manufacturing industry, Drug Establishment Licences, GUI-0002, licence requirements
Federal

The purpose of this guidance is to provide information to prospective cell therapy product clinical trial sponsors to assist them in satisfying applicable Federal regulatory requirements as set out in Division 5 – Clinical Trial Applications of the Food and Drug Regulations.

Last Updated: Jun. 2, 2021
Date Published: Aug. 21, 2015
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, clinical trial applications, sponsors, cell therapy products, cell therapy products, in humans, federal regulatory requirements, Food and Drug Regulations
Federal

These guidelines are meant to help companies in the drug manufacturing industry and health care professionals understand how to comply with regulations, specifically drug establishment licence (DEL) requirements in Part C, Division 1A of the FDR.

Last Updated: Sep. 17, 2020
Date Published: Apr. 1, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Drug Establishment Licences, comply with drug establishment licence regulation.
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