A Success But Room For Improvement: Canada’s Conditional Approval Pathway

Ninety-two approvals, seven revocations and myriad standard-of-care treatments are all discussed in a first-of-its kind study examining the data and nuances of oncology submissions processed under Health Canada’s 26-year-old notice of compliance with conditions (NOC/c) pathway.

A number of cancer medicines that were fast-tracked in Canada are now standard-of-care treatments • Source: Shutterstock

Most of the oncology medicines that received a conditional marketing approval in Canada between 2018 and 2021 have become standard-of-care treatments for their respective indications.

On the other hand, many of the confirmatory trials that are needed to fulfil the conditions of the approval are not completed fast enough, but there are ways this could...

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