Expanding Our Scientific Advice Services for the Life Sciences Sector in Canada

Canada’s Drug Agency is launching a new 1-year learning period in our Scientific Advice program that will expand the type of guidance we offer to drug manufacturers to include those that are seeking advice after a “do not reimburse” recommendation is issued for their product.

During the learning period, we will provide advice on plans for new clinical evidence generation intended for drugs that were not recommended for reimbursement and that may be resubmitted to our Reimbursement Review program. To qualify, manufacturers must be planning to generate new clinical evidence that will address gaps identified in our final recommendation. New clinical evidence plans may include real-world evidence.

This new offering will have shorter timelines and a lighter process compared to our standard Scientific Advice and can be customized to meet the needs of the drug sponsor. Applications for this new process can be submitted until June 30, 2025. As part of the process, applicants must consent to the sharing of the advice report and related information within Canada’s Drug Agency. The advice and related information will not be shared with the expert review committee or in a public document.

This development is part of our continued “test and learn” approach to enhancing Canada’s drug reimbursement ecosystem and our efforts to help patients and health systems benefit from innovative products.

For more information, please contact [email protected].