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Found 10 records similar to Improving the regulatory review of drugs and devices: Expanding priority review pathways for drugs that meet health care system needs

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 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

This guidance aims to articulate Health Canada's expectations and generate a level of consistency regarding the interpretation of the Priority Review of Drug Submissions policy and the filing of a Priority Review request. Additional clarification of the process by which the Priority Review request is assessed is provided.

Last Updated: Jul. 7, 2021
Date Published: Jul. 6, 2012
Organization: Health Canada
Formats: HTML
Keywords:  Guidance for industry, priority review of drug submissions, interpretation of the priority review of drug submissions policy, priority review request
Federal

Health Canada's drug products fact sheet describes how drugs are reviewed in Canada including how drugs are developed and submitted for authorization to conduct clinical trial.

Last Updated: Sep. 17, 2020
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Drug review, priority review, fast-track, life-saving drugs, expedited, and authorization for clinical trial.
Federal

Present the list of new drug submissions (NDSs) that are currently being reviewed.

Last Updated: Sep. 17, 2020
Date Published: Oct. 23, 2016
Organization: Health Canada
Formats: HTML
Keywords:  Drug submission, submissions under review, drug and health product review and approval.
Federal

Following several successful joint reviews between Australia, New Zealand and Canada, there has been interest by others within industry to explore this as a model for bringing new veterinary drug products to market. Industry has been keen to understand how to initiate discussions and how the overall process would work. This document is therefore provided as guidance for industry about the joint review process for veterinary drugs.

Last Updated: Jul. 8, 2021
Date Published: Feb. 12, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Guidance, veterinary drug, veterinary drug joint reviews
Federal

Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed in this document.

Last Updated: Nov. 8, 2021
Date Published: Sep. 16, 2021
Organization: Public Health Agency of Canada
Formats: HTML
Keywords:  Coronavirus, disease, COVID-19, COVID, health, product, industry, Drugs, vaccines
Federal

Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed here.

Last Updated: Aug. 26, 2021
Date Published: Jul. 30, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, drug, vaccine, drug and vaccine authorizations, list of authorized drugs, list of authorized vaccines, expanded indications
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