Guidance for market authorization requirements for COVID-19 drugs: Overview

Guidance for market authorization requirements for COVID-19 drugs: Overview 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. 2022-07-28 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyCOVID-19COVID-19 drugsmarket authorization requirementsdrug manufacturedsoldregulatory process Guidance for market authorization requirements for COVID-19 drugs: OverviewHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/guidance-market-authorization-vaccines.html Guidance for market authorization requirements for COVID-19 drugs: OverviewHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/guidance-market-authorization-vaccines.html

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.

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