Guidance for market authorization requirements for COVID-19 vaccines: Rolling submissions, non-clinical and clinical requirements (French, HTML)

Guidance for market authorization requirements for COVID-19 vaccines: Rolling submissions, non-clinical and clinical requirements: French HTML file. From Health Canada, updated Jul 2021. View metadata, licence and the direct download on CanQuery.

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HTML

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Publisher-reported update

2021-07-27

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.

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