Description
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.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Guidance for market authorization requirements for COVID-19 drugs: Rolling submissions and reviews | HTML | Open resource | |
| Guidance for market authorization requirements for COVID-19 drugs: Rolling submissions and reviews | HTML | Open resource |