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Found 10 records similar to Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: Drug establishment licences and good manufacturing practices
This document provides guidance to drug manufacturers seeking authorization for their drug manufactured, sold, or represented for use in relation to COVID-19. The guidance explains recent changes to the regulatory process for new COVID-19 drugs.
As of June 16, all COVID-19 datasets will be updated weekly on Thursdays by 2pm. This dataset details the percentage of COVID-19 positive patients in hospitals and ICUs for COVID-19 related reasons, and for reasons other than COVID-19. Data includes: * reporting date * percentage of COVID-19 positive patients in hospital admitted for COVID-19 * percentage of COVID-19 positive patients in hospital admitted for other reasons * percentage of COVID-19 positive patients in ICU admitted for COVID-19 * percentage of COVID-19 positive patients in ICU admitted for other reasons Due to incomplete weekend and holiday reporting, data for hospital and ICU admissions are not updated on Sundays, Mondays and the day after holidays. This dataset is subject to change.
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.
Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed in this document.
Variant strains of SARS-CoV-2 are emerging that may affect the level of protection provided by currently authorized COVID-19 vaccines. As a result, manufacturers are adapting authorized COVID-19 vaccines to provide protection against infection and disease caused by virus variants.
Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed here.
COVID-19 is a new disease. A vaccine or therapy to treat or prevent this disease has not yet been developed. However, the COVID-19 pandemic has resulted in a global review of therapies that may be used to treat or prevent the disease. Canada is speeding up the importation and sale of medical devices used to diagnose, treat or prevent COVID-19.
What being vaccinated against COVID-19 means for me. By getting vaccinated, you benefit from the protection you get against COVID-19 and the easing of restrictive measures in your community.
The purpose of this document is to assist in planning immunization clinics for COVID-19 vaccines during the COVID-19 pandemic.
The medicine regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom (Access Consortium) have discussed the regulatory evidence requirements for COVID-19 vaccine approvals and considerations for post-market pharmacovigilance. This collective statement on COVID-19 vaccines builds on the Consortium's May 2020 pledge to work together to counter the COVID-19 global pandemic.