Scientific Advice Offered at Different Time Points

Sponsors may apply for Scientific Advice at different time points, including but not limited to:

1. Pre-Pivotal Trial: Advice on pivotal trial(s) before the finalization of protocol(s). This may include questions related to real-world evidence (RWE) plans.
2. Post-Pivotal Trial: Advice on RWE plans before regulatory approval. This may include questions related to the pivotal trial (e.g., population, comparators, outcomes) and potential gaps in evidence.
3. After a drug product receives a Do Not Reimburse recommendation from Canada’s Drug Agency. This may include questions related to RWE or trials being planned to address gaps identified in the recommendation. This is part of a 1-year learning period pilot program ending on June 30 2025.

Questions related to health economic evaluation plans may be included at any time point.

Please contact [email protected] to discuss potential applications that fall outside these eligibility criteria.