Health Canada Releases Revised Guidance Document Re Drug Name Review

Health Canada recently released a revised Guidance Document entitled "Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names". The document is intended to clarify the way information and material related to proposed drug names submitted by drug companies is handled by the Health Products and Food Branch. As defined in the Guidance Document, "look-alike sound-alike (LA/SA) health product names refer to names of different health products that have orthographic similarities and/or similar phonetics (i.e. sound similar when written or spoken)". The similarities could pose a health risk by causing errors in the prescribing, dispensing or administration of a product. Following a review and analysis by the Biologics and Genetic Therapies Directorate of the issues associated with LA/SA health product names, in March 2004, Health Canada had released a policy document entitled "Issue Analysis Summary: Look-alike Sound-alike (LA/SA) Health Product Names: The Development of a Comprehensive Policy Recommendation". According to a notice released by Health Canada, the Guidance Document was developed to implement the pre-market recommendations outlined in the earlier Issue Analysis Summary. The terms of the Guidance Document apply to all drug submission types received by Health Canada from January 1, 2006, its effective date. For a copy of Health Canada's Guidance Document, visit: http://makeashorterlink.com/?V59713B2C To see the Issue Analysis Summary: Look-alike Sound-alike (LA/SA) Health Product Names: The Development of a Comprehensive Policy Recommendation, visit: http://makeashorterlink.com/?R10923B2C Summary by: Lenni Carreiro