Selection process of INNs
How are INNs selected?
Usually, requests for INNs are submitted directly to WHO. In some countries, where national nomenclature commissions exist, this may also be done through the corresponding national nomenclature authority, for example the United States Adopted Names Council (USAN) for requests originating from the United States.
Precise information on the chemistry, pharmacological action and therapeutic use, as well as suggested nonproprietary names, name and address of the manufacturer are to be provided along with the request.
Each name proposed by the originator of a request for an INN is then examined and a name selected in accordance with the revised procedure for the selection of recommended International Nonproprietary Names for pharmaceutical substances:
International Nonproprietary Names: revised procedure (EB115/11 - 2004)
The annexes of the revised procedure provide detailed information on the following:
- Procedure for the selection of recommended international nonproprietary names for pharmaceutical substances (Annex 1)
- Working process for the INN Expert group (Appendix to Annex 1)
- General principles for guidance in devising international nonproprietary names for pharmaceutical substances (Annex 2)
- Fasibility of speeding up the INN selection process and making newly selected INN available to the public before their official publication in WHO Drug Information (Annex 3)
All INN Experts designated to select nonproprietary names have to agree to the name which is then first published as a proposed INN. During a four-month period, any person can forward comments, or lodge a formal objection to a name, e.g. on grounds of similarity with a trade-name. If no objection is raised the name will be published a second time as a recommended INN.