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

View metadata and access the original French HTML file: Guidance for market authorization requirements for COVID-19 vaccines: Rolling submissions, non-clinical and clinical requirements.

Format

HTML

Access

file-only

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.

Access original file