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Found 10 records similar to Clinical Trials For Natural Health Products

Federal

Clinical trials are an important step in health product development. As products evolve, so do clinical trial types and designs. Clinical trial studies increasingly focus on individualized treatments rather than larger patient groups. New technologies are also changing the way we conduct studies.

Last Updated: Jun. 7, 2022
Date Published: Feb. 4, 2022
Organization: Health Canada
Formats: HTML
Keywords:  regulatory-innovation for health-products, regulatory-innovation for health-products, clinical-trials, regulatory innovation, modernizing clinical-trial regulations
Federal

This manual is based on Health Canada's Guidance for Clinical Trial Sponsors: Clinical Trial Applications and other applicable guidance documents. It is designed to provide tools and relevant links in order to facilitate the successful filing of a Clinical Trial Application (CTA) to Health Canada.

Last Updated: Jun. 7, 2022
Date Published: May 9, 2007
Organization: Health Canada
Formats: HTML
Keywords:  clinical trials manual, clinical trial sponsors, clinical trial applications, CTA, facilitate successful filing
Federal

This manual is based on Health Canada's Guidance for Clinical Trial Sponsors: Clinical Trial Applications and other applicable guidance documents. It is designed to provide tools and relevant links in order to facilitate the successful filing of a Clinical Trial Application (CTA) to Health Canada.

Last Updated: Jun. 2, 2021
Date Published: May 9, 2007
Organization: Health Canada
Formats: HTML
Keywords:  clinical trials manual, human clinical trials, regulatory obligations, dugs for clinical trials involving human subjects
Federal

Phase I-III clinical trials involving natural health products on human subjects must be authorized by Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD) before commencement of the trial.

Last Updated: Sep. 13, 2021
Date Published: May 11, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Clinical Trials, Phase I-III clinical trials, involving, natural, health, products, on, human subjects, authorized
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

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

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

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

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

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
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