2007-11-04-世界卫生组织-Guidance_on_the_establishment_of_new_INN_stems_-_20070611_2页_29kb

INN Working Doc. 07.215
11 June 2007, Geneva

Guidance on Establishing New INN Stems

This document outlines the INN Programme's official policy and provides guidance on establishing new stems for International Nonproprietary Names (INNs).
The intent is to address the increasing frequency of INN requests seeking new stems for novel compounds.

Key Points:

1. Background: New stems should not be established for compounds unless they demonstrate a confirmed novel mode of action and conclude the existing stem structures are inadequate.
2. Policy: The INN Programme prefers using existing stems* whenever possible. New stems are only considered for groups of at least several substances showing a confirmed novel mode of action where inclusion in existing structures or derived names (prefixes/suffixes) is insufficient.
3. Guidance: Submission of substantial clinical and preclinical data is required to prove that existing nomenclature does not apply to a requested new stem.
4. Importance: Maintaining a limited set of stems ensures the uniqueness and clarity of future INN assignments, crucial for healthcare practitioners. It also prevents hindering the creation of generic names (T/M names) by discouraging trade names based on existing stems.
5. Documentation: Recommendations stem from resolutions of the WHO Executive Board and the World Health Assembly. More details on the INN stem system are available in two INN documents: "The use of stems...", and its Addendum.