Guidance for market authorization requirements for COVID-19 drugs: Rolling submissions and reviews (English, HTML)

Guidance for market authorization requirements for COVID-19 drugs: Rolling submissions and reviews: English HTML file. From Health Canada, updated Jul 2022. View metadata, licence and the direct download on CanQuery.

Format

HTML

Access

Original download only

Publisher-reported update

2022-07-28

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). The ability to review data from early development while later-stage clinical trials are taking place helps to expedite the regulatory review process.

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