Open Government Portal

Found 10 records similar to Guidance on applications for drug clinical trials under the interim order: Overview

Federal

The guidance documents contain information for applicants seeking authorization to conduct COVID-19 drug and medical device clinical trials under Interim Order (IO) No. 2.

Last Updated: May 28, 2021
Date Published: May 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, Interim Order, IO No.2, coronavirus, COVID-19, clinical trials, drug, medical device, clinical trial authorization
Federal

The purpose of this document is to provide guidance to manufacturers of serological assays intended for the detection of antibodies to SARS-CoV-2, the virus that causes COVID-19 disease. The guidance outlines recommendations regarding the minimum testing that should be performed for SARS-CoV-2 diagnostics.

Last Updated: May 11, 2020
Date Published: Apr. 24, 2020
Organization: Public Health Agency of Canada
Formats: HTML
Keywords:  COVID-19 pandemic, Antibody tests, serological assays.
Federal

The Interim Order (IO) No. 2 continues to support the optional pathway introduced by IO No. 1 to facilitate clinical trials for potential COVID-19 drugs and medical devices.

Last Updated: May 28, 2021
Date Published: May 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, Interim Order No. 2, Clinical Trials, Medical Devices and Drugs Relating
Federal

IO No. 2 continues to support the optional pathway introduced by IO No. 1 to facilitate clinical trials for potential COVID-19 drugs and medical devices.

Last Updated: May 28, 2021
Date Published: May 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, Interim Order No. 2, notice, clinical trials, medical devices, drugs, authorization to conduct clinical trials
Federal

IO No. 2 supports Canada’s continued focus on dealing with the significant risk that COVID-19 continues to pose to the health and safety of Canadians.

Last Updated: May 28, 2021
Date Published: Apr. 28, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, Interim Order No. 2, notice, clinical trials, medical devices, drugs, risks, health and safety
Federal

Health Canada has developed this guidance document in order to support the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 pursuant to subsection 30.1(1) of the Food and Drugs Act. This Interim Order will allow the Department to issue expedited authorization for sale or import of medical devices to deal with the current significant risk of COVID-19 to the health and safety of Canadians.

Last Updated: Apr. 30, 2021
Date Published: Mar. 26, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, guidance document, applications for medical devices, application for the sale or importation of medical devices, Interim Order
Federal

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. This guidance document is intended to provide guidance to manufacturers and importers to organize and submit an application in a timely manner for the sale or importation of medical devices that are manufactured, sold or represented for use in relation to COVID-19.

Last Updated: Sep. 25, 2020
Date Published: Apr. 2, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Applications for medical devices, Interim Order, COVID-19 related Medical devices, foreign regulatory authority, Drug product announcements.
Federal

Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment; the Minister of Health, pursuant to subsection 30.1‍(1)Footnote 1 of the Food and Drugs ActFootnote 2, makes the annexed Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.

Last Updated: Nov. 4, 2020
Date Published: Sep. 16, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, Interim Order, notice, explanatory note, importation, sale and advertising of drugs, a significant risk to health, safety or the environment
Federal

Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment; the Minister of Health, pursuant to subsection 30.1‍(1)Footnote 1 of the Food and Drugs ActFootnote 2, makes the annexed Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.

Last Updated: Nov. 18, 2020
Date Published: Sep. 16, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, Interim Order, notice, explanatory note, importation, sale and advertising of drugs, a significant risk to health, safety or the environment
Federal

This interim order (IO) provides more tools for urgently addressing drug shortages related to COVID-19.

Last Updated: Apr. 30, 2021
Date Published: Oct. 16, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, Interim Order, prevention and alleviation of shortages of drugs, drug shortages related to COVID-19
Date modified: