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Found 10 records similar to How Drugs are Reviewed in Canada
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.
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.
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.
How to access a list of generic drug submissions currently under review.
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.
Present the list of new drug submissions (NDSs) that are currently being reviewed.
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.
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.
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.
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.