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These measures expedite the regulatory review of COVID-19 health products without compromising safety, efficacy and quality standards. These measures …

Record Modified: Jul 29, 2021
Record Released: Jul 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic medical devices regulatory measures measures expedite the regulatory review

The guidance document concerning amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19 …

Record Modified: Jul 27, 2021
Record Released: Jul 27, 2021
Publisher: Health Canada
Formats: HTML
Keywords: coronavirus COVID-19 pandemic drugs medications vaccines market authorization licensing importing or selling COVID-19 vaccine labelling requirements post-market requirements

Variant strains of SARS-CoV-2 are emerging that may affect the level of protection provided by currently authorized COVID-19 vaccines. …

Record Modified: Jul 27, 2021
Record Released: Jul 27, 2021
Publisher: Health Canada
Formats: HTML
Keywords: coronavirus COVID-19 pandemic drugs medications vaccines market authorization licensing importing or selling COVID-19 vaccine SARS-CoV-2 variants

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 …

Record Modified: Jul 27, 2021
Record Released: Jul 27, 2021
Publisher: Health Canada
Formats: HTML
Keywords: coronavirus COVID-19 pandemic drugs medications vaccines market authorization licensing importing or selling COVID-19 vaccine rolling submissions non-clinical requirements ...

This document provides guidance on developing the evidence and documentation needed to obtain an authorization and licensing for importing or …

Record Modified: Jul 27, 2021
Record Released: Jul 27, 2021
Publisher: Health Canada
Formats: HTML
Keywords: coronavirus COVID-19 pandemic drugs medications vaccines market authorization licensing importing or selling COVID-19 vaccine

Coronavirus, COVID-19, pandemic, outbreak, testing, diagnosis, contact tracing, testing devices, point-of-care, POC, antigen, antibodies, molecular, FDA, non-laboratory use

Record Modified: Jul 27, 2021
Record Released: Jul 27, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Coronavirus COVID-19 pandémie épidémie test diagnostic recherche des contacts dispositifs de test point de service POC antigène anticorps Coronavirus COVID-19 ...

the Minister of Health signed the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary …

Record Modified: Jul 27, 2021
Record Released: Jul 27, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic exceptional importation sale of medical devices Interim Order extends and modifies certain measures large-scale public health emergencies regulatory processes

The tables below list the COVID-19-related clinical trials which have been authorized by Health Canada through the Food and …

Record Modified: Jul 27, 2021
Record Released: Jul 27, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic vaccines for COVID-19 drugs for COVID-19 list of authorized clinical trials

the Minister of Health signed the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary …

Record Modified: Jul 27, 2021
Record Released: Jul 27, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic exceptional importation sale of drugs medical devices foods for a Special Dietary Interim Order extends and modifies certain measures large-scale public health emergencies regulatory processes

How Health Canada is addressing clinical trials of drugs and vaccines, its expedited review process and the Special Access Program …

Record Modified: Jul 27, 2021
Record Released: Jul 27, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic vaccines for COVID-19 drugs for COVID-19