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Found 10 records similar to Notice to Stakeholders: Statement on the Investigational Use of Marketed Drugs in 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

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

Health Canada is issuing this Notice to clinical trial sponsors to clarify the approach to various types of clinical research with cannabis.

Last Updated: Dec. 29, 2021
Date Published: Sep. 11, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Food and Drug Regulations, clarification of requirements, clinical trial sponsors, clinical-research with cannabis, cannabis clinical research
Federal

Health Canada is issuing this Notice to clinical trial sponsors to clarify the approach to various types of clinical research with cannabis.

Last Updated: Dec. 29, 2021
Date Published: Sep. 11, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Food and Drug Regulations, clarification of requirements, clinical trial sponsors, clinical-research with cannabis, cannabis clinical research
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

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

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

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

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

This refers to the situation where a clinical trial is not initiated by a commercial sponsor. In this case, the institution / investigator assumes the regulatory responsibilities of a clinical trial sponsor.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  clinical trial sponsor, institution or investigator, investigator initiated clinical-trials, commercial sponsor, investigator, regulatory-responsibilities
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