Guidance for market authorization requirements for COVID-19 vaccines: Rolling submissions, non-clinical and clinical requirements
Guidance for market authorization requirements for COVID-19 vaccines: Rolling submissions, non-clinical and clinical requirements is an open dataset from Health Canada with 2 files (HTML); catalogue record updated 2021-07-27. On CanQuery you can follow the original downloads. Files are available in English and French.
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.
- Publisher
- Health Canada
- Resources
- 2
- Catalogue metadata updated
- 2021-07-27
Data overview
- Formats
- HTML
- File languages
- English, French
Official sources and licences
Resources
- Guidance for market authorization requirements for COVID-19 vaccines: Rolling submissions, non-clinical and clinical requirements (English, HTML) HTML · Download HTML
- Guidance for market authorization requirements for COVID-19 vaccines: Rolling submissions, non-clinical and clinical requirements (French, HTML) HTML · Download HTML