In the pharmaceutical branding world, the only constant is change when it comes to regulation among the global health authorities. Governing bodies from the FDA to Health Canada to EMA are in a continuous adaptation to evolve the process of gaining approval of a drug. These include many factors related to an asset’s development, up to and including the brand naming. And in this situation, knowing what is ahead of you is half the battle.
For instance, Health Canada recently released a new set of regulatory naming requirements for all drugs to be marketed in Canada. This is a big step in a new direction for the agency, and with this new direction comes new challenges for manufacturers developing products.
Therefore, it makes sense for pharmaceutical organizations to look to partner with those who have their finger on the pulse of these directional changes, and who have the processes in place to navigate the rough waters of change.
Regulatory and Brand Name Tests
With these changes, the regulatory bodies around the world are driving the industry toward more predictable outcomes when it comes to name testing—a trend that is good for everyone. With an increase in transparency and better communication of best practices, pharma and healthcare brands will have a better understanding of how to consistently create and test brand names that will have a higher chance of approval.
An additional benefit and goal of these organizations is to further reduce the chance of medication error when it comes to name confusion. These types of errors aren’t good for anyone—patients, healthcare professionals and brands all see how an error can have devastating impacts, and the trend toward eliminating the chances of these errors is seen as a positive across the board.
Following the Health Canada announcement, I put together a webinar to explain the changes, the reasoning behind the decision from Health Canada and what manufacturers can (and should) do when developing a product to be marketed in Canada.
Getting it right the first time is crucial for the progress and success of any asset, and in turn, important to the manufacturer in charge of its development. Regulatory stipulations in regard to testing and submitting names has expanded in recent years—and now more so than ever.
If the name does not follow the new published guidelines, it can potentially delay launch. This means, if an organization chooses to cut corners on its brand name development and testing process, they could potentially be setting themselves up for a disaster.
So for organizations looking to develop the next great product, take my word and look to partner with branding and naming agencies who understand that the more you know, the better chance you have to succeed.