In 2017, Health Canada started a five-year initiative on improving regulatory review of drugs
and devices (R2D2). The goal of this initiative was to develop an agile regulatory system
that supports better access to therapeutic products based on healthcare system needs.
The outcome should result in a modern and flexible operational system with an updated
infrastructure supported by an appropriate cost recovery framework. This system will allow
access to clinical information to the public. To achieve this goal, Health Canada developed a
plan for transformation in three major areas:
• Collaboration with health partners
• Access to drugs and devices
• Use of real-world evidence
This paper provides overview of the plan, discusses up-to-date progress and gives a glimpse
into the future.
By Oxana Iliach, PhD, Sr. Director, Regulatory Strategy and Policy, Certara