Health Canada Sharpens Regulatory Requirements for Naming

FDA Health Canada

Name Challenges in Pharmaceutical Brand Naming

The pharmaceutical market is highly regulated. Not only are there laws to restrict the information that is being spread to the public as with the HWG-law in Germany (Heilmittelwerbegesetz), but there are also guidelines for naming that tell you exactly what needs to be taken into account, and more importantly, what needs to be ruled out. Two main principles are that the name may not include a promotional message of any kind like “QuickestDrug”, and that it should not be misleading. In this context “misleading” means that the name should not suggest that the pharmaceutical can be indicated for a certain disease or dysfunction for which it, in fact, is not. For example, “Coughinex” for a medication against sleep disorder would not work. Apart from those two rules, many others exist that naming agencies, that are focused on pharmaceutical naming, need to be aware of. The overall objective is to have clear, suggestive and easily-pronounceable names, which contribute to patients’ safety by eliminating confusion.

The Strictest Regulations – FDA and Health Canada

Most countries have such a guideline that regulates naming requirements. Two crucial countries are the USA with the regulatory authority FDA and Canada with Health Canada. Both regulatory authorities require a name testing with doctors and HCPs. Health Canada has just announced that they have sharpened their requirements and strongly recommend a larger sample size of doctors. This will apply from the middle of the year 2015. The simulation tests with HCPs are designed to minimize the risk of confusion orally (pronunciation and verbal understanding) as well as orthographically.

Patients as Target Group

Besides the regulatory issues and the target group, advertising is designed quite differently. This is due to the fact that the pharmaceutical industry does not and/or should not push the product to the consumers. Instead it is strived that the consumers know the name of the product when they need it, in other words, in the instance that they are ill. Therefore, advertising is less straight-forward than that of FMCGs. The right balance needs to be found.

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