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On January 29, 2026, Canada's Drug Agency (CDA) published Improvements to the Drug Reimbursement Review Process, which includes a section for consultation on proposed changes to the reimbursement review process. Proposed changes include:
- a new streamlined review process, including a new project schedule to ensure publication of a final recommendation within 180 days following initiation of review.
- new reconsideration procedures to streamline a request for reconsideration. Notable changes will treat a request for reconsideration as a new project; standardize reconsideration timelines; clarify that new analyses/studies will be addressed through resubmission, not reconsideration; provide a new opportunity for input from patient and clinician groups; and result in publication of a new reconsideration report.
- new resubmission procedures to clarify when a resubmission can be streamlined and applicable review timelines: standard (180 days), streamlined (150 days) and reconsideration (120 days).
- new eligibility criteria for Testing Procedure Assessments (TPAs) to provide clear guidance on when a TPA will be undertaken based on updated "scope" and "relevance" criteria. Notably, the scope will expand to incorporate complementary tests (alongside companion diagnostics). Additionally, TPA requirements will focus on tests that introduce new health system impacts, reducing requirements for companion diagnostics that are part of routine care.
Feedback can be provided until February 26, 2026.
The same document also includes two sets of summaries of procedural revisions and clarifications that the CDA considers operational or administrative in nature, one set is effective January 29, 2026 and the other set will be implemented for the December 2026 committee meetings.
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 technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
