Draft guidance on management of rolling reviews for drug submissions: Applying for rolling review status

Name: Draft guidance on management of rolling reviews for drug submissions: Applying for rolling review status
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

To apply for rolling review status for a forthcoming new drug submission (NDS) or supplement to a new drug submission (SNDS), sponsors must provide a Rolling Review Application Package (RRAP). The RRAP is forwarded to the appropriate directorate and assessed within 45 calendar days.

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2023-09-01

Data overview

Formats: HTML
File languages: English, French

Official sources and licences

Government of Canada Open Data
Open Government Licence – Canada

Resources

Draft guidance on management of rolling reviews for drug submissions: Applying for rolling review status (French, HTML) HTML
Draft guidance on management of rolling reviews for drug submissions: Applying for rolling review status (English, HTML) HTML

Related open data

Health Canada