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Information about filtering facepiece respirators and their certification and testing process.

All Canadian-manufactured respirators must meet the minimum performance testing requirements.

For an IO submission, Health Canada requires a report on the results of the performance testing requirements that apply to the product class. Any deviations should be identified and explained.

Due to the urgent public health needs relating to COVID-19, we can issue a market authorization with conditions. This is done to support early access to promising health products when the potential benefits outweigh the potential risks.

At the time of authorization, no major safety concerns have been reported in the available data submitted to Health Canada. We are carefully monitoring the post-market (after authorization) safety and effectiveness of authorized COVID-19 vaccines. As part of our commitment to keep Canadians...

Information on the Moderna COVID-19 vaccine, including how it works, how it's given, possible side effects and vaccine safety after authorization.

As part of the government’s broad response to the pandemic, Health Canada introduced a number of innovative and agile regulatory measures. These measures expedite the regulatory review of COVID-19 health products without compromising safety, efficacy and quality standards. These measures are...

The guidance document concerning amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19 indicates that the plain language labelling requirements for mock-up labels and a brand name assessment package do not apply (C.08.002(2)(j.1) and C.08.002(2)(o)). Although not...

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.

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,...