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Found 10 records similar to Guidance for market authorization requirements for COVID-19 drugs: Rolling submissions and reviews
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.
What you, and what communities can do to lower the spread of COVID-19 in settings including social services, workplaces, outdoors, community, religious, transport and remote and Indigenous communities.
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). Before filing a submission for a rolling review, sponsors of clinical trials are expected to have gathered a certain level of evidence on the safety, quality and efficacy of their vaccine.
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.
Many potential drugs and treatments for use against COVID-19 are being evaluated in Canada and around the world. Several different types of treatments have been developed.
How Health Canada is addressing clinical trials of drugs and vaccines, its expedited review process and the Special Access Program to find therapies to prevent or treat COVID-19.
Several different types of treatments for COVID-19 have been developed. Examples include drugs that reduce or stop the virus from multiplying in human cells and drugs that treat the symptoms of COVID-19.
The COVID-19 Emergency Loan Program for Canadians Abroad is a temporary financial assistance program to help Canadians travelling outside Canada to return home or to shelter in place while they arrange to return to Canada. This dataset provides information on the number and value of loans issued by country.
Parents, caregivers and children across the country are facing new challenges as the COVID-19 pandemic affects our daily work and home routines. Schools, daycares and most workplaces have closed, and children and parents are suddenly at home full-time.
Mathematical modelling of COVID-19 pandemic which uses mathematical equations to estimate how many cases of a disease may occur in the coming weeks or months.