Vol. 4 No. 5 (2024)
Viewpoint

Viewpoint: Reflections on an Analysis of Health Canada’s NOC/c Policy for Oncology Drug Approvals

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Published May 31, 2024

Key Messages

  • This project provided an opportunity to examine the data and nuances of oncology submissions processed under Health Canada’s Notice of Compliance With Conditions (NOC/c) policy.
  • While Health Canada's transparency mechanisms typically focus on individual submissions, our examination across all submissions over time provided us with a comprehensive resource. This allowed us not only to observe the extent to which confirmatory studies align with approved indications, but also to understand the impact of our decisions under the NOC/c policy.
  • Looking ahead, this study underscores the importance of maintaining mechanisms for reviewing promising new medications and emphasizes the significance of confirmatory trials. Real-world evidence may play an important role in supplementing confirmatory studies and providing additional support for the use of these products.