By the Numbers: The Regulatory Path Forward
July 22, 2025
In this issue, we’re taking a deep dive into three initiatives that are aimed at speeding up regulatory drug approvals: Health Canada’s Priority Review (PR) and Notice of Compliance with Conditions (NOC/c) pathways, and the multinational collaboration Project Orbis. Here are some of the facts and figures about the three programs.
1996: Health Canada institutes the Priority Review (PR) pathway.3
1998: Health Canada introduces the Advance Consideration for Notice of Compliance with Conditions (NOC/c) policy.6
19%: Proportion of all new drugs approved by Health Canada in 2024 that went through the PR (20 files) and/or the NOC/c (2 files) pathway.4
2019: Launch of Project Orbis, an international partnership of regulatory agencies that aims to streamline reviews and shorten approval timelines for promising cancer treatments.2
74: Health Canada approvals that have been reviewed through Project Orbis between 2019 and 2024, an average of 12 per year.4,2
8: Countries participating in Project Orbis as of 2025, including Canada.9
530: Average number of days from NOC to first provincial listing for Project Orbis drugs in Canada – slightly less than the 598-day figure for Canadian drugs as a whole reported in 2024.10
References
2. Project Orbis. Government of Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/international-activities/project-orbis.html
3. Guidance for industry : Priority Review of drug submissions. Health Canada. https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/priordr-eng.pdf
4. 20Sense original research.
6. Guidance document : notice of compliance with conditions (NOC/c). Health Canada. https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/compli-conform/noccg_accd-eng.pdf
9. Project Orbis. US Food & Drug Administration. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
10. IQVIA Market Access Metrics, December 2024.