The Canadian Regulatory Landscape for Pharmaceutical Brand Naming

Pharmaceutical brand naming is a crucial aspect of the Canadian healthcare industry as it helps to create a unique identity for a drug and differentiates it from other products in the market. In Canada, pharmaceutical brand naming is a regulated process that involves adherence to specific guidelines and requirements set by Health Canada, and Brand Institute (BI) and Drug Safety Institute (DSI) have a great deal of experience navigating this landscape. 

One of the primary reasons for the regulation of pharmaceutical brand naming is to ensure patient safety. The name of a drug must be unique and, at the same time, easy to pronounce, spell, and remember to avoid confusion with other medications that have similar names. Additionally, the name should not imply a misleading indication, and it should not be associated with any other medical terms or health claims. 

Unlike other jurisdictions, the naming approval process begins and ends with the drug submission process: there is no pre-approval or acceptance of a drug brand name by Health Canada. The pharmaceutical company must provide the proposed brand name for its product with evidence to support its safety for Health Canada’s evaluation. This Look-alike Sound-alike (LASA) data package includes screening criteria, prescription simulation studies, and safety evidence supporting its use. This includes the proposed name’s similarity to other drug names, the potential for name confusion, and the consequences should medication error occur. Unlike other jurisdictions, drug name approval occurs at the same time the drug is approve: there is no name acceptance or pre-approval drug name status in Canada. 

Pharmaceutical brand naming in Canada is a highly regulated process designed to protect patient safety by preventing brand name confusion and misleading indications. The process is designed to minimize medication error potential by thoroughly testing a brand name with healthcare professionals, in a variety of scenarios, before it is allowed to be used in Canada.

By Scott Sawler