On July 27, the CLHIA responded to Health Canada’s accelerated drug review pathway draft guidance, suggesting revisions in the areas of substantial evidence and promising evidence, as well as transparency in bridging indications from an established indication to a new indication. The CLHIA also suggested that there be more clarity and coordination among the national organizations assessing rare drugs, including Health Canada, pCPA, CADTH and INESSS. The draft guidance is meant to provide assistance to industry regarding the criteria to access an accelerated review, what a Notice of Compliance with conditions (NOCc) means to the manufacturer, the collection of real world evidence for rare diseases as well as other information important to manufacturers and insurers.