Updated Procedures for Reimbursement Reviews
On April 30, 2026, Canada’s Drug Agency (CDA) published updated Procedures for Reimbursement Reviews, following completion of a public consultation earlier this year. The updated procedures will be effective for August 2026 submissions and expert committee meetings in January 2027. Notable updates include:
- A streamlined review process, including a new project schedule, which will target publication of a final recommendation in 180 calendar days. Following consultation, CDA will continue to publish draft recommendations for a public feedback period of 10 business days and will not reduce the 7 business-day period for sponsor comments on the draft report.
- An enhanced reconsideration process, including disclosure of the sponsor’s reason for reconsideration; publication of the review reports presented to the expert committee; and clarification that new analyses or studies will be addressed through resubmission, not reconsideration. Following consultation, CDA will continue to collect feedback from patient and clinician groups on draft recommendations for a period of 10 business days, but will not implement a proposed new period for reconsideration-specific input.
- A streamlined resubmission process, introducing criteria for standard (180 days) and streamlined (150 days) resubmissions. A streamlined resubmission may be permitted when, among satisfying other criteria, the sponsor includes only one new source of clinical information.
- Updated eligibility criteria for testing procedure assessments (TPAs). A test will be eligible for a TPA based on meeting updated scope and relevance criteria. As reported at the time of consultation, “scope” will expand to incorporate complementary testing procedures (alongside companion diagnostics), and “relevance” will focus on new health system impacts.
- Sponsor advance notification, requiring sponsors to provide 50 business days of advance notice for anticipated submissions, resubmissions, or reassessments.
New data on Health Technology Assessment timelines
CDA has previously published data on Canada’s drug system as part of the Data Systems and Analytics Program, including for oncology and non-oncology drugs from 2020-2024. On April 17, 2026, CDA released new data on Health Technology Assessment timelines and provided key takeaways for 2024, as compared to prior years 2020-2023:
- Time to draft recommendation: 92% of sponsored reviews were issued a draft recommendation within 180 days of acceptance for review, more than the average of 86% from 2020 to 2023.
- Time to final recommendation: Median time from submission to final recommendation was 206 days, including 15 days (submission to acceptance), 147 days (acceptance to draft), and 38 days (draft to final). The mean time from submission to final recommendation was 234 days. including 16 days (submission to acceptance), 166 days (acceptance to draft), and 53 days (draft to final).
- Pre-NOC submissions were received for a median of 119 days prior to regulatory approval, followed by a median of 48 days from approval to draft recommendation. 66% (33) of the completed pre-NOC reviews were submissions that were filed with CDA at least 91 days in advance of regulatory approval.
- Post-NOC submissions had a median of 119 days between Health Canada approval and post-NOC submission to CDA, 13% less than the median from 2020 to 2023 (136 days). 45% of post-NOC submissions were filed with CDA within 90 days of Health Canada approval and 30% were submitted more than 1 year after approval.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation 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.