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Found 10 records similar to Improving the regulatory review of drugs and devices: Drugs - Special Access to Drugs and Health Products

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: May 5, 2020
Date Published: Jul. 5, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Special Access Program, Non-marketed drugs.
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

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

Drugs are authorized for sale in Canada once they have successfully gone through the drug review process, which includes the assessment of the safety, efficacy and quality of the drug. However, Health Canada's SAP allows practitioners to request access to drugs that are not available in Canada for the emergency treatment of patients with serious or life-threatening conditions who have exhausted other treatment options.

Last Updated: Dec. 29, 2021
Date Published: Jul. 21, 2021
Organization: Health Canada
Formats: HTML
Keywords:  notice of clarifications, access to restricted-drugs, Special Access Program, SAP, drug review process, access to drugs, not-available for emergency-treatment, life-threatening conditions, other treatment options
Federal

This project will result in Health Canada and Health Technology Assessment (HTA) organizations working together. This will allow them to give scientific advice to manufacturers at the same time early in the drug development process.

Last Updated: Sep. 17, 2020
Date Published: Feb. 16, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Early scientific advice, Health Canada and Health Technology Assessment.
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

Immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment. Therefore, the Minister of Health, pursuant to subsection 30.1(1)Footnote1 of the Food and Drugs ActFootnote2, makes this Interim Order: Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19.

Last Updated: May 1, 2020
Date Published: Mar. 20, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19 pandemic, risk to health and safety, Interim Order, Drugs, Medical Devices and Foods for a Special Dietary Purpose.
Federal

The Drug Facts Table for Non-prescription Drugs Guidance Document gives direction for designing safe and clear labels and packages.

Last Updated: Sep. 9, 2021
Date Published: Aug. 21, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHPs, Non-prescription drugs, a new Drug Facts Table, supporting improved labelling
Federal

The Access to Drugs in Exceptional Circumstances regulatory pathway enables access to drugs which have been authorized for sale in certain foreign jurisdictions, but are not available in Canada, to address urgent public health needs. This pathway is intended for public health events that are exceptional in nature and that are occurring (or imminent) and require immediate action.

Last Updated: Dec. 29, 2021
Date Published: Sep. 9, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Access to Drugs, exceptional circumstances, regulatory pathway, authorized for sale, urgent public-health needs
Federal

Interim Order No. 2 Respecting Drugs, Medical Devices, and Foods for a Special Dietary Purpose in Relation to COVID-19 (Interim Order No. 2) was signed on March 1, 2021.

Last Updated: Apr. 30, 2021
Date Published: Mar. 25, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, Interim Order No. 2, Drugs, Medical Devices and Foods, a Special Dietary
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