Brand Institute's Vice President of Creative Nomenclature Explains the Pharmaceutical Brand Name Review Process Used by Japanese Regulators

MIAMI, Jan. 31, 2023 /PRNewswire/ -- In most countries and geographical regions, government health agencies review brand names composed of Latin characters (the letters of the English alphabet). Pharmaceutical manufacturers will submit brand name proposals to a health agency for review, and that agency will assess those names for similarity to existing brand names in that country or region. If a name is too similar to another name based on that agency's guidelines, the proposed brand name may be rejected.

"In Japan, the brand name review process is much different," said Sanae Suga, Brand Institute's Vice President of Creative Nomenclature. English brand names are transliterated into katakana, a component of the Japanese writing system. The katakana transliteration is meant to match the English pronunciation of the Latin rendering. The transliterated name is then screened through a program run by the Japan Pharmaceutical Information Center (JAPIC) to compare the name against other katakana names.

The JAPIC's program places significant emphasis on prefix similarity. If the prefix of a proposed katakana name is identical to the prefix of an approved katakana name, the new name is likely to be rejected by Japan's Ministry of Health, Labour and Welfare (MHLW), a regulatory agency comparable to the US FDA. "Brand Institute has a proprietary program that that mimics the JAPIC's program to help our clients with their Japanese regulatory submissions."

Brand Institute is the global leader in pharmaceutical and healthcare-related name development, with a portfolio of over 4,000 marketed healthcare brand names, 1,300 USAN/INN nonproprietary names for 1,200 clients. The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year with healthcare manufacturers. Drug Safety Institute is composed of former naming regulatory officials from global government health agencies, including Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), American Medical Association (AMA), and the World Health Organization (WHO). These regulatory experts co-authored the name review guidelines with their respective agencies, with many responsible for ultimately approving (or rejecting) brand name applications. Now working for a private company, these professionals provide Brand Institute's clients with industry-leading guidance pertaining to drug name safety (i.e., preventing medication errors), packaging, and labeling.

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James Dettore 
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[email protected] 
www.brandinstitute.com

SOURCE Brand Institute, Inc.