Pharmaceutical Regulatory Bodies Across The Globe

Posted April 17, 2017 by
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Creating a name for a new pharmaceutical compound is uniquely complex. Not only is achieving creative viability for a name in a market with over 1.3 million trademarks an intricate task, but companies are also faced with the accompanying intense regulatory testing of these names for ultimate submissions. This regulatory scrutiny becomes even more complicated when companies wish to achieve a globally consistent name for their compound, as the name must be submitted to the corresponding regulatory bodies for approval. Global consistency begins with an in-depth understanding of major regulatory bodies including: Health Canada in Canada, the Food and Drug Administration (FDA) in the United States, and the Name Review Group (NRG) in Europe.

All three of these groups –along with others such as the Ministry of Health, Labour, and Welfare in Japan– oversee the pharmaceutical naming evaluation processes and ensure that products are being named appropriately. Essentially, their goal is to ensure drug names are not “overly fanciful” in their promotion, the name does not “include or imply an ingredient that is not included in the drug product,” and that the name cannot “cause confusion in print, handwriting, or speech with the name of another medicinal product.”

Although all these regulatory organizations have the same goal of consumer safety, there are some differences in the approaches and processes:

  • One of the most notable differences among the three is that Health Canada is the only one to require some form of testing, simulation, or database searching, prior to name submission. While Health Canada my be the only one to require testing, of course the FDA and the European Medicines Agency (EMA) –of which the NRG is a part– strongly recommend that companies do their own safety testing prior to name submission.
  • A seemingly obvious, but none-the-less important, distinction between the groups is the languages in which they review name candidates. Being based in the US, the FDA only evaluates names in English, while Health Canada has to account for both English and French. Lastly, the NRG evaluates names within all the various languages spoken within the 28 members countries of the EU.
  • All three regulatory bodies adhere to different schedules, deadlines, and rules. For example, the NRG allows two name submissions at the same time, while the FDA and Health Canada review one name at a time. To achieve global harmony, which is a primary goal for most new globally marketed products, it is vital to coordinate submissions within those review schedules. A submission strategy, with a detailed timeline, is critical to achieve Brand name singularity.

An understanding of these regulatory bodies and their unique aspects and differences is a crucial part of pharmaceutical Brand naming. Any Company looking to hire an agency to undertake a naming project needs to have the confidence that the agency will guide them through the regulatory process and that their agency understands how to create a truly global Brand name. Agencies will need to know how to utilize all the tools at their disposal –like POCA– and have built a process that ensures that only optimal, ownable Brand identities are selected and submitted to regulatory and legal bodies.

Tags:

Healthcare | Legal | Pharmaceutical Naming | Regulatory

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