Being a world-class global pharmaceutical naming agency is more than just providing stellar creative options. Final name recommendations must also be optimal from a trademark, a commercial and a regulatory perspective. Trademark review is conducted independently by paralegals and attorneys. Consider drug name safety testing from a team that understands both regulatory guidelines and market research principles before you select the brand name for an Agency review.
What is Drug Name Safety Testing?
Name safety testing, originally called “Name Safety Research,” is a process of evaluating and prioritizing proposed proprietary (invented) names being considered for submission to a regulatory agency. Dyan Rowe Davis, B.S. Pharm, R.Ph., J.D. and President of Brandsymbol’s Regulatory Division, started using this term early in her career to help distinguish this type of evaluation model from traditional market research. Aspects of a traditional market research are the foundation for “Name Safety Testing” including developing a proper screening instrument, panel or respondent recruitment activities, questionnaire development, programming surveys, data collection, data analysis and presentation of results. However, the main objective for drug name safety testing is to help prioritize a list of proposed name candidates based on metrics rooted in a regulatory review. These metrics are also designed to help prevent medication errors due to sound-alike and look-alike similarity and avoid names that have potential promotional claims that could lead to a misleading claim or confusion in practice. In most circumstances, there is a combination of qualitative data and quantitative data that incorporates regional considerations based on the relevant regulatory body that will review the name candidates. In addition, it is best practice to also include commercial metrics such as ease of pronunciation, fit to concept, recall and favorite choice to provide an overall recommendation of a name candidate based on regulatory and commercial performance.
Why conduct Name Safety Testing?
Name safety testing can help prioritize names based on regulatory risk which ultimately helps the sponsor select a name for submission.
When a brand (invented) name is submitted a regulatory agency such as the United States Food & Drug Administration, only one name is reviewed at a time. If the drug being developed is in the investigational stage of development or IND phase, then the review time for one name is 180 days. If the drug being developed is in the New Drug Application or NDA phase, then the review time for the one name is 90 days.
If there is a rejection of the one name, the sponsor of the application will submit a new name as a backup name or alternative name and the review clock (180 days or 90 days) starts – again!
A brand name review process is slightly different for each regulatory body. Name safety testing should incorporate each of the relevant geographic areas where the names are being considered for submission.
Is Safety Testing Required?
For most Agency reviews, (i.e., US/FDA, Europe/EMA, United Kingdom/MHRA, Brazil/ ANVISA), name safety testing data for submissions is not required. However, name safety testing data is required for a proprietary name submission to Health Canada.
If you have any questions or are not sure if you should conduct name safety testing, please contact us and we will be happy to help.