Developing a new pharmaceutical brand name can be a complex process, particularly in Japan where there are unique guidelines and regulations. Japan is one of the largest pharmaceutical markets in the world and has a high demand for new medications.
In most countries, government health agencies including the FDA, EMA and Health Canada, review brand names composed of Latin characters, i.e., letters of the “English” alphabet. During this review process, if a name is found to be too similar to another marketed name based on that agency’s guidelines, the proposed brand name may be rejected. Japan has a similar review process, but with some very distinct and notable differences.
In Japan, pharmaceutical products are typically identified by their Katakana name, which is a Japanese script used for foreign words. However, since the Katakana name may not be easily understood by non-Japanese speakers, the MHLW also requires that pharmaceutical products have both katakana and a transliterated name that uses the English alphabet (Latin characters). This helps to ensure that the name of a pharmaceutical product is easily recognizable and understood, regardless of the language or region. If a product will be marketed globally, as is often the case, English alphabet letters will be created first and then the katakana transliterated name. 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 program places significant emphasis on prefix similarity. If the first 3 katakana letters of a proposed name is identical or highly similar to the prefix of an approved katakana name, the new name is likely to be rejected Japan’s Ministry of Health, Labour and Welfare (MHLW).
Once a list of potential names has been created, the company must conduct a thorough trademark search to ensure that the brand name is not already in use or too similar to existing names. This is to avoid any potential legal issues that may arise in the future.
After the trademark search has been completed, the company can submit the brand name to the MHLW for review. The review process typically takes between two and six months and involves an evaluation of the proposed brand name to determine if it meets the regulatory requirements.
If the MHLW approves the brand name, the company can then register the name with the Japan Pharmaceutical Manufacturers Association (JPMA) and the Japan Generic Medicines Association (JGA), which are responsible for maintaining a database of all approved brand names in Japan. The company must also file for trademark protection with the Japanese Patent Office to prevent any unauthorized use of the brand name.
It may sound very complicated but there are agencies who can help you make this process easier. Brand Institute has a proprietary program that mimics the JAPIC program, which helps our clients understand the regulatory viability of proposed katakana transliterations. It’s important that companies who intend to submit to Japan—or who are even considering submitting to MHLW at some point in the product’s lifespan—know the potential challenges in advance, especially if they are pursuing a global name.
By Sanae Suga