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Health Canada is offering an option for a rolling review of a new drug submission (NDS) or supplement to a …
To apply for rolling review status for a forthcoming new drug submission (NDS) or supplement to a new drug submission …
Sponsors must complete the fee section of the Regulatory Enrolment Process (REP) Regulatory Transaction (RT) template. The RT template provides …
Data or information provided after the submission is filed in accordance with the notice of rolling review status will not …
The time to complete the screening of a drug submission with a rolling review is 25 days. Once the screening …
Sponsors will be issued an invoice for the full fee related to examining the NDS or SNDS once Health Canada …
Submissions formerly under review: New drug submissions
Submissions currently under review: New drug submissions
Submissions formerly under review: Supplemental new drug submissions for new uses
The objective of this document is to ensure that sponsors of SRTDs have the necessary information to satisfy the regulatory …