Guidelines for Establishing Generic Drug Names
For Japanese pharmaceutical development startups aiming to enter the global market.
Please note: Machine translated. Please refer to the original Japanese for accuracy. Doing business in Japan typically requires Japanese-speaking staff or local support.
Generic Drug Naming Systems
| Item | INN (International Nonproprietary Name) | JAN (Japanese Accepted Name) | USAN (United States Adopted Name) |
|---|---|---|---|
| Governing Body | World Health Organization (WHO) | Ministry of Health, Labour and Welfare (PMDA) | USAN Council (AMA, etc.) |
| Role | Global standard. Ensures patient safety and scientific communication. | Identifies drugs within Japan. In principle, conforms to INN. | Identifies drugs within the US. A primary gateway to obtaining an INN. |
Reference URLs
- International Nonproprietary Names, WHO: https://www.who.int/teams/health-product-and-policy-standards/inn
- Handling of Japanese Accepted Names for Pharmaceuticals, MHLW: https://www.mhlw.go.jp/web/t_doc?dataId=00tc6442&dataType=1&pageNo=1
- United States Adopted Names, AMA: https://www.ama-assn.org/about/united-states-adopted-names-usan
The Stem System: A Drug's Identity
What is a Stem?
A stem is a specific word segment (morpheme) used in common for a group of pharmacologically related drugs. It allows healthcare professionals to intuitively understand a drug's class from its name.
-vastatin: HMG-CoA reductase inhibitors-prazole: Proton pump inhibitors-mab: Monoclonal antibodies
General Naming Principles
In addition to using stems, all name candidates must adhere to the following principles:
- Clarity and Uniqueness: Easy to pronounce and remember.
- Non-suggestive: Should not suggest a therapeutic effect.
- Consideration for International Pronunciation
Naming Process & Timeline
The process takes approximately 18-28 months from internal preparation to final registration.
1. Preparation
2-4 months
2. Domestic Consultation
1-2 months
3. Intl. Application
2-3 months
4. WHO Review
6-9 months
5. Objection Period
4 months
6. rINN Rec.
2-3 months
7. JAN Registration
1 month
Key Points for Success
① Thorough Research
The biggest risk is conflict with existing trademarks or names. Thoroughly investigate whether candidate names (especially their pronunciation) conflict with similar trademarks.
② Early Start & Integration
Name selection is a critical path that takes over 18 months. It should be initiated no later than the start of Phase II clinical trials and managed within the overall development plan.
③ Use USAN as a Gateway
When conducting clinical development in the US, applying for a USAN is the most efficient route to obtaining an INN. It is the standard path for global expansion.
Effectively Utilize PMDA's Consultation Services
Utilizing PMDA's free consultation service before applying to the WHO is an effective risk-hedging strategy.
About INN Application Consultation
This consultation allows you to obtain the views of the Japanese regulatory authorities in advance, significantly reducing uncertainty during the international review process. The optimal time is during the Phase II clinical trial stage.
Disclaimer
This page was created based on publicly available information and past experience.
For actual naming and application procedures, please be sure to refer to the latest information and consult with the PMDA and other relevant authorities.