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Found 10 records similar to How Drugs are Reviewed in Canada

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

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 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

How to access a list of generic drug submissions currently under review.

Last Updated: Sep. 17, 2020
Date Published: Nov. 29, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Drug submission, generic submissions under review, drug and health product review and approval.
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

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

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

Modified requirements for COVID-19 drugs allow for the filing of rolling submissions (section C.08.002(2.3) of Canada's Food and Drug Regulations). The ability to review data from early development while later-stage clinical trials are taking place helps to expedite the regulatory review process.

Last Updated: Jul. 28, 2022
Date Published: Oct. 29, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, COVID-19 drugs, market authorization requirements, drug manufactured, sold, regulatory process, rolling submissions-and-reviews
Federal

Instructions for complying with the Requirements of Canada's Access to Medicines Regime specify how to notify the World Trade Organization or the Government of Canada, and how to request the addition of a particular drug or medical device to the list of eligible products.

Last Updated: Sep. 17, 2020
Date Published: Mar. 29, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, comply with procedures, requirements of Canada's Access to Medicines Regime, addition of a particular drug or medical device to the list of eligible products.
Federal

Before drugs can be sold to Canadians, they must meet high safety and quality standards. This is the case for drugs made in Canada or abroad. Learn about drug inspections, how the Government of Canada (GC) conducts them and our licensing practices.

Last Updated: Apr. 27, 2021
Date Published: Oct. 28, 2016
Organization: Health Canada
Formats: HTML
Keywords:  drug inspections, inspection database, regulated inspections processes
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