2010-12-30-世界卫生组织-INN_Stem_Book_2011_187页_791kb

Summary of "The Use of Stems in the Selection of International Nonproprietary Names (INN) for Pharmaceutical Substances"

Core Content

This document outlines the use of stems in the selection of International Nonproprietary Names (INNs) for pharmaceutical substances, as part of the World Health Organization (WHO) INN Programme. The INN Programme is responsible for assigning unique, non-proprietary names to pharmaceutical substances to ensure clear identification, safe prescription, and international communication among health professionals. The use of common stems helps categorize substances based on their pharmacological activity, making the naming system more systematic and meaningful.

Main Objectives

• To provide guidance on the use of stems in the selection of INNs.
• To assist applicants, reviewers, and interested parties in understanding the INN naming process and stem classification.
• To offer a comprehensive list of common stems and their definitions for pharmaceutical substances.
• To highlight the rules and criteria for selecting INNs, including phonetic and spelling considerations.

Main Views and Key Information

1. INN Selection Procedure

• The WHO Expert Panel is responsible for selecting INNs.
• The process involves a formal review, and the selected name is published as a proposed INN.
• A four-month period is allowed for public comments or objections.
• If no objections are raised, the name becomes a recommended INN.

2. Stem Classification and Use

• Stems are used to denote pharmacological groups.
• The stem classification system is described in Part III and includes codes (e.g., A, B, C, etc.).
• Preferred stems are used to reflect the main activity of the substance.
• The use of stems is optional, but it is encouraged for consistency and clarity.

3. Criteria for INN Selection

• INNs should be distinctive in sound and spelling.
• They should be short enough to avoid confusion with common names.
• The use of certain letters (e.g., "h", "k") is avoided to ensure pronunciation across languages.
• Phonetic and spelling rules are applied to facilitate international use.

4. Stem List and Definitions

• The document includes a detailed list of stems in Part II A.
• Each stem is associated with a specific pharmacological category.
• Definitions for each stem are provided in Part II B, which is alphabetical and comprehensive.
• Some stems are no longer formally acknowledged (marked with (d)), while others are included as examples (marked with (x)).

5. Part IV: Stems and Corresponding INNs

• Part IV lists all proposed INNs (Lists 1–105) that include INN stems.
• It is organized alphabetically and includes INNs that:
  • Use the preferred stem in accordance with its definition.
  • Use the preferred stem but not in accordance with its definition.
  • Belong to the same group but do not use the preferred stem.
• Additional information is provided to help users understand the layout and use of this part.

6. Annexes

• Annex 1: Describes the procedure for selecting INNs.
• Annex 2: Provides general principles for devising INNs.
• Annex 3: Explains the nomenclature for monoclonal antibodies.
• Annex 4: Covers the nomenclature for gene therapy products.
• Annex 5: Lists publications where proposed INNs have been published.
• Annex 6: Explains why INNs are important and outlines the achievements of the INN Programme.

Conclusion

The INN stem system is a key tool in the standardization of pharmaceutical nomenclature. It helps ensure clarity, consistency, and safety in drug naming across the globe. The document provides a detailed reference for those involved in the naming and review process, offering guidance, rules, and definitions to support international communication and regulatory use.