Data-driven analysis of regulatory drug submissions and reimbursement reviews
Canada’s Drug Agency (CDA-AMC) published data on Canada’s drug system as part of the Data Systems and Analytics program.
The new data cover the following information for oncology and non-oncology drugs from 2020-2024:
- regulatory drug submissions to and approvals from Health Canada
- new drug approvals submitted to CDA-AMC for reimbursement review to undergo a Health Technology Assessment (HTA)
- the number of HTA submissions and HTA recommendations issued by CDA-AMC
- the type of HTA recommendations issued by CDA-AMC
The data were primarily obtained from the Drug and Health Product Submissions Under Review (SUR) list and the CDA-AMC reimbursement review reports.
The key takeaways from the newly released data are:
- drug submissions increased by 10% and drug approvals decreased by 15% in 2024 compared to the past 4 years
- oncology drugs accounted for 32% of drug submissions and 27% of approvals in 2024
- 48.5% of new drug approvals were submitted for reimbursement review from 2020-2024
- HTA submissions increased by 11% in 2024 compared to the past four years, with 71% of submissions filed before Health Canada issued a notice of compliance
- CDA-AMC issued 10% more HTA recommendations in 2024 compared to the past four years, with 43% of the recommendations issuing for oncology drugs
- 93% of HTA recommendations in 2024 were to reimburse with clinical criteria and/or conditions
New resource released on Canada’s regulatory and drug access pathways
On December 3, 2025, CDA-AMC released Drug Access in Canada: Understanding the System. This resource explains the steps in Canada’s drug approval and reimbursement pathway, including:
- clinical trials
- regulatory review by Health Canada
- HTA recommendations for listing drugs on publicly funded drug plans
- drug pricing negotiations and formulary listings
- measures to prevent excessive pricing of patented medicines
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.