Earlier this year, Health Canada released the Guidance Document for Industry - Review of Drug Brand Names. With a view to revisiting the 2006 Guidance document currently in force, and to replacing the Draft Revised Guidance released in February of 2013, the new Guidance aims to provide greater clarity regarding the nature of the evidence required in the drug name submission process and to reduce the risk of medication errors due to look-alike sound-alike drug names. It is scheduled to come into force on June 13, 2015. In contrast to the 2013 Draft Revised Guidance, the new Guidance does not require evidence of psycholinguistic testing in the risk assessment process for LA/SA drug names.
Click here to view the new Guidance.
Click here to view the question and answer sheet respecting the new Guidance that was released today.