Health Canada Submissions Under Review

These pages also include summaries of certain submissions that were accepted into review and subsequently cancelled by the sponsor.

Health canada submissions under review. About the generic submissions under review gsur list. Applications received related to the covid 19 pandemic applicant. For eligible submissions new drug submissions and eligible supplemental new drug submissions accepted into review on or after october 1 2018 the submission class will be added to the lists of submissions currently under review.

Consequently a subsequent entry manufacturer is not allowed to file a submission for a generic drug for the first six years of the eight year period. The lists will help canadians. The gsur list was announced as part of phase iii of the submissions under review sur list initiative.

On january 7 2019 health canada published a notice soliciting feedback on possible impacts and uses to stakeholders if the gsur list is updated to include sponsor names i e the company that filed the generic submission. Identify substances accepted for review in canada. About the submissions under review sur lists.

The rdss include the purpose of the submission and the reason for the decision. Rejected by health canada cancelled by the company consult the drug and health product submissions under review sur list and the generic submissions under review list to access submissions under review that are not related to the covid 19 pandemic. Make better decisions about their health.

Health canada consulting on the contents of the generic submissions under review list. Beginning october 1 2018 health canada will publish a new list of abbreviated new drug submissions andss on the submissions under review sur list as well as publish regulatory decision summaries rdss for andss supplemental abbreviated new drug submissions sandss and certain supplemental new drug submissions sndss. Health canada will be informing canadians through a phased approach on the canada ca website of new drug submissions nds for new active substances nas for both pharmaceuticals and biologics that are accepted into review on or after april 1 st 2015.

Health canada will conduct a preliminary assessment while the drug is under review nds and the sponsor will be notified of the outcome. On january 7 2019 health canada opened a consultation on whether to include the names of sponsor companies on the generic submissions under review list gsur for abbreviated new drug submissions andss. The submissions under review sur lists help to make our review processes more transparent.