The following blog reflects regulatory guidance as of JUNE 2025.
The World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee meets twice a year – in the spring and fall.
Question: Does the United States Adopted Names (USAN) Council also meet twice a year?
Answer: No. The USAN Council has a rolling submission process and sponsors should estimate 2-3 months review time for a completed application.
Conducting conflict checks on proposed nonproprietary names is required with the USAN application.
Question: Are there any other metrics that should be considered before selecting names for the USAN Council to review?
Answer: Absolutely. Although there can be changes to the submitted name(s) by USAN and INN, it is good idea to conduct a linguistic review for any potential meanings or associations based on the word parts in the nonproprietary name. In addition, Brandsymbol recommends a trademark review direct search based on the first five-letters of the nonproprietary name as an additional conflict check. Remember, nonproprietary names may be found unacceptable based on conflicts with other nonproprietary names, brand names, chemical, homeopathic products, etc.
Question: If I have more than one possible naming scheme for a compound, can I include both naming schemes in the short list of names?
Answer: Yes. To show your due diligence in evaluating the most appropriate naming scheme, include a brief description of the naming schemes explored and include a rationale of why one is most appropriate.
WHO INN has one form but there are several different USAN application forms.
Question: What is the difference in application forms and are there different fees associated with the applications?
Answer: INN submissions should be made via a mandatory electronic application form. There is one form for INN and the Fee for an INN application is $12,000 USD. For a USAN submission, you must select the appropriate application form based on your compound. Each application form has a different fee. Here is a quick summary of the USAN Forms and Fees:
- Form A: Single Entity Drug and Salt Form, Fee $28,000 USD.
- Form B: Singel Entity Form, Fee $18,000 USD.
- Form C: Modified Compound Form, Fee $10,000 USD.
- Form D: Revise Established USAN Form, Fee $5,000 USD.
- Form E: Contact Lens Material Form, Fee $18,000 (new).
- Form F: Biologics Form, Fee $18,000.
A few notes from the USAN Council’s Winter Hybrid Meeting held Friday December 6, 2024:
- There was a slight increase in new submissions.
- 31 negotiations were discussed: 11 biologics, 2 multiple-round, 9 new negotiations, 4 open-ended negotiations, 2 INN actions and 3 protac substances.
- USAN sponsored 16% of the new INN applications discussed (38 USAN-sponsored applications.
- New stems approved by council:
- For more details: https://www.ama-assn.org/about/united-states-adopted-names-usan/usan-council
A few notes from WHO’s 14 January 2025 INN 79th Executive Summary:
- Discussions included 249 new INN requests, of which 155 were for biological substances. As a result of these discussions:
- 263 new names were selected, which are planned to be published in List 132 (COVID-19-related requests only) and List 133 proposed INN (p.INN).
- 10 requests did not fulfil INN criteria (No INN)
- New stem/substems selected:
- For more details: https://www.who.int/publications/m/item/inn-24-611
We welcome any additional questions regarding the nonproprietary naming process. Please reach out at www.brandsymbol.com or to me directly at dyan@brandsymbol.com.