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Found 10 records similar to Improving the regulatory review of drugs and devices: Early scientific advice to manufacturers

Federal

The Health Canada and Health Technology Assessment (HTA) review processes are independent of each other. Aligned reviews project will make sure that the timing of Health Canada and Canadian HTA reviews are better aligned.

Last Updated: Sep. 17, 2020
Date Published: Jun. 22, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Aligned reviews, Health Canada and Health Technology Assessment.
Federal

The updated regulations will help drug makers understand what information should be included in their drug submissions. This will help with product approval and availability.

Last Updated: Sep. 17, 2020
Date Published: Feb. 16, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Improving access to generic drugs, regulatory review of drugs and devices.
Federal

The Special Access Programme (SAP) provides access to nonmarketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada.

Last Updated: Sep. 17, 2020
Date Published: Jul. 5, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Special Access to Drugs and Health Products, Special Access Programme, access to nonmarketed drugs.
Federal

This project will build new review pathways for those drugs shown to meet health care system needs. The outcome for the people of Canada will be faster access to drugs, including drugs for rare diseases.

Last Updated: Sep. 17, 2020
Date Published: Feb. 16, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Priority review, faster access to drugs, health care system needs.
Federal

This notice outlines the safety and effectiveness requirements for closed system devices that decontaminate medical devices using ultraviolet (UV) radiation. The notice is for manufacturers using an interim order (IO) authorization or medical device licence application.

Last Updated: Jan. 6, 2021
Date Published: Nov. 6, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, UV, ultraviolet radiation, UV decontamination devices, decontaminate medical devices, closed system devices, notice to manufacturers
Federal

COVID-19 is a new disease. A vaccine or therapy to treat or prevent this disease has not yet been developed. However, the COVID-19 pandemic has resulted in a global review of therapies that may be used to treat or prevent the disease. Canada is speeding up the importation and sale of medical devices used to diagnose, treat or prevent COVID-19.

Last Updated: Apr. 7, 2020
Date Published: Apr. 2, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, COVID-19 pandemic, importation and sale of medical devices, diagnose, treat or prevent COVID-19, list of COVID-19 Diagnostic Device.
Federal

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.

Last Updated: Jul. 24, 2020
Date Published: Apr. 2, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Coronavirus, COVID-19, pandemic, clinical trial for COVID-19 medical devices, authorized clinical trials
Federal

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.

Last Updated: Jun. 7, 2022
Date Published: Apr. 6, 2022
Organization: Health Canada
Formats: HTML
Keywords:  clinical-trials, clinical-trials for COVID-19-medical-devices, list of authorized-clinical-trials
Federal

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices. Authorization is done through the Medical Device Regulations or the Interim Order No. 2 for clinical trials for medical devices and drugs related to COVID-19.

Last Updated: Jun. 30, 2021
Date Published: Jun. 14, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, clinical trials, drugs, medical devices, apply for a trial authorization, Medical Devices Regulations, interim order for clinical trials related to COVID-19, list of authorized clinical trials
Federal

This website provides continually updated official Government of Canada advice and information to help ensure the safety and well-being of Canadians travelling and living abroad, with a focus on the Security, Entry/Exit Requirements, Health, Laws & Culture, Natural Disasters & Climate, and Help Abroad of destinations around the world.

Last Updated: Jul. 29, 2020
Date Published: Apr. 2, 2020
Organization: Global Affairs Canada
Formats: HTML
Keywords:  Cousular Services, Counsular Assistance, Travel, Travel Advice, Travel Advisories, Travel Health, Safety, Entry and exit requirements, Laws and customs
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