On 28 February 2019 Health Canada released a Notice to Industry: Health Canada and CADTH launch new initiative to provide early parallel scientific advice. 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 relating to market authorisation and reimbursement in Canada. Through this new initiative, drug sponsors can obtain advice from Health Canada and the CADTH in parallel.
The initiative will enable Health Canada and the CADTH to collaborate and share perspectives while each formulating independent advice regarding a sponsor's specific drug development plan. It will also give sponsors the opportunity to have a joint meeting with Health Canada and the CADTH to discuss their advice. The initiative will:
- follow the same general process and timelines as the CADTH's Scientific Advice Programme;
- be non-binding and confidential; and
- result in a separate written record of scientific advice from both Health Canada and the CADTH.
Early parallel scientific advice can be sought on topics such as:
- target population;
- choice of comparator;
- trial design and duration;
- end points; and
- 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:
- drugs for rare diseases or conditions or other challenging clinical populations;
- new therapeutic areas;
- complex, adaptive or unusual trial designs; or
- 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 that are interested in participating in this initiative should contact the CADTH.
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