Guidance for market authorization requirements for COVID-19 drugs: Rolling submissions and reviews

Name: Guidance for market authorization requirements for COVID-19 drugs: Rolling submissions and reviews
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

Guidance for market authorization requirements for COVID-19 drugs: Rolling submissions and reviews is an open dataset from Health Canada with 2 files (HTML); catalogue record updated 2022-07-28. 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). The ability to review data from early development while later-stage clinical trials are taking place helps to expedite the regulatory review process.

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2022-07-28

Data overview

Formats: HTML
File languages: English, French

Official sources and licences

Government of Canada Open Data
Open Government Licence – Canada

Resources

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

Related open data

Health Canada