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Found 10 records similar to Improving the regulatory review of drugs and devices: Notice to industry - Aligned reviews between Health Canada and health technology assessment organizations
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.
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.
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.
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.
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.
Present the list of new drug submissions (NDSs) that are currently being reviewed.
As Canada’s nuclear regulator, the CNSC reviews the environmental protection measures put in place for every facility we regulate. The Environmental Protection Review report series offers a summary of CNSC staff’s technical assessment of how effectively licensees are protecting human health and the environment in the communities in which they are operating.
The purpose of the report is to share CNSC staff’s findings from the review of SRBT's environmental protection measures. This includes any possible environmental releases as part of normal operations, and the risk of radiological or hazardous substances posed to the environment and human health.
COVID-19 is a new disease not previously identified in humans. Currently there is no vaccine or therapeutic product for COVID-19 that is authorized to treat or prevent the disease. The outbreak of COVID-19 has resulted in a global review of therapies that could be used to treat or prevent the infection. In an effort to facilitate earlier access to a vaccine, or therapeutic product for COVID-19, the Department will expedite the review of any COVID-19 related health product submissions and applications.
This guidance document Federal Contaminated Site Risk Assessment in Canada Supplemental Guidance: Checklist for Peer Review of Detailed Human Health Risk Assessments (HHRA) was prepared to provide guidance for custodial departments.
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.