About the Scientific Advice Program

The Scientific Advice Program is a voluntary, fee-for-service consultation offered to pharmaceutical companies. Through this program, we offer advice on drug development plans from the perspective of health technology assessment in Canada.
Scientific Advice is offered at different timepoints during the clinical development of a drug product. Advice is offered during the planning stages of pivotal trials or after protocols for pivotal trials are finalized. Scientific Advice is nonbinding and confidential.

Benefits of Scientific Advice for Pharmaceutical Companies

For pharmaceutical companies, the benefit of receiving Scientific Advice is reduced uncertainty in the drug development process. Through the Scientific Advice program, pharmaceutical companies can receive guidance on what Canada’s Drug Agency considers to be rigorous and relevant evidence for a future submission to the Reimbursement Review program for their drug product.

Pharmaceutical companies also have the opportunity to consider Scientific Advice in the context of global information and advice. Understanding consistencies and inconsistencies in requirements across health technology assessment agencies internationally may enhance global drug development strategies.

“The advice report equipped me to advocate for my market access goals with global colleagues.”
-    Market Access Manager, Canadian Affiliate of  Global Pharma Company

Benefits of Scientific Advice for Canada’s Drug Agency as Well as Decision-Makers and Patients in Canada

For Canada’s Drug Agency, the Scientific Advice program provides an opportunity to influence the clinical evidence generated for future submissions to the Reimbursement Review program, potentially leading to stronger and more relevant evidence upon which to base reimbursement recommendations. Stronger recommendations benefit decision-makers in Canada who use the recommendations to create policies related to drug reimbursement, and patients in Canada who are impacted by the policies put in place.

The Scientific Advice program also provides an opportunity for the agency to gain early knowledge of new methodologies and approaches on the horizon. This knowledge can be used to better prepare Reimbursement Review teams for the challenges they may encounter with future drug assessments.