On February 28, 2019, Health Canada released a Notice to Industry announcing the Early Parallel Scientific Advice initiative. Currently, Health Canada and the Canadian Agency for Drugs and Technologies in Health (CADTH) offer separate processes for drug sponsors seeking early advice on evidence related to market authorization and reimbursement in Canada. Through this new initiative, drug sponsors can obtain advice from Health Canada and CADTH in parallel.
The initiative will enable Health Canada and CADTH to collaborate and share perspectives while each formulating independent advice regarding a sponsor's specific drug development plan and will also give sponsors the opportunity to have a joint meeting with Health Canada and CADTH to discuss the advice. The initiative will follow the same general process and timelines as CADTH's Scientific Advice Program, will be non-binding and confidential, and will result in a separate written Record of Scientific Advice from both Health Canada and CADTH.
Early Parallel Scientific Advice can be sought on topics such as (1) target population; (2) choice of comparator; (3) trial design and duration; (4) end points; and (5) statistical issues. New drug products, existing drug products with new indications, drugs for rare diseases, and oncology products are all eligible for the initiative. According to the Notice, Early Parallel Scientific Advice is most beneficial for (1) drugs for rare diseases or conditions or other challenging clinical populations; (2) new therapeutic areas; (3) complex, adaptive, or unusual trial designs; or (4) development plans that may include the use of real-world evidence.
Applications must be filed early in the drug development cycle, when adjustments to protocols for pivotal trials are still feasible. Drug sponsors interested in participating in this initiative should contact CADTH.
If you have any questions or would like further information, please contact a member of our firm’s Pharmaceutical and Life Sciences 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.