2008-06-08-世界卫生组织-INN_45th_Executive_Summary_10页_204kb

报告摘要

45th Consultation on International Nonproprietary Names for Pharmaceutical Substances Summary

Meeting Outcome: Geneva, November 19-21, 2007. Presented by World Health Organization (WHO) Programme on International Nonproprietary Names (INN), Quality Assurance and Safety, Medicines (QSM), Medicines Policy and Standards (PSM).
Key Results: Discussed 116 INN cases (72 new, 35 deferred previously, 3 proposed with objections, 6 substitutions). Approved 95 new names for publication in List 99, deferred 11 cases, rejected 1 new name (met non-INN criteria), withdrew 1 objection, and planned an amendment in List 99.

Focus Areas & Challenges:

Biological Substances: Debates frequent, especially "biosimilars." Greek letter identifiers remain standard for glycoforms but lack inter-agency definition consistency (INN, BAN, USAN, JAN). Recommended review of INN definitions based on JAPAN's new approach emphasizing origin, cell type, and structure. Epoetin case highlights ongoing challenges in process variability affecting glycoforms and defining profiles.
Fixed-Dose Combinations (FDCs): Increased generic availability leads to naming and labeling mess. Current INN practice (no abbreviations) is cumbersome; potential solutions involving standard abbreviations or codes are explored, but clarity and user adoption are challenges.
International Manufacturing Codes (Method): No governing body code exists; INN prefers descriptive stems, but considering optional identifiers (like BAN's approach). JAN's new guidelines include manufacturing method information.
Standardization Efforts:
- WIPO Cooperation: Assisting INNs not be trademarked. Agreeing to share INN info with WIPO member states. WIPO exploring standards for shortened trade name identifiers.
- UNII (Unique Ingredient Identifier): Joint USP/FDA project assigns alphanumeric codes for substances, independent of spelling variations or legal status.
- IUPAC/INCI: InChI (Chemical Identifier) aims for unique, reversible structure identification. Consensus on nomenclature, especially stereochemistry, is challenging.
- USAN: Finalized 150 applications in 2007. Annual meeting plans for 2008 in Phoenix, AZ.
- Publications: La Revue Prescrire in France promotes INN stems. Russian progress and challenges in adopting INN-based systems and translation.
- EC/TAXUD-B3: Continues collaboration with customs authorities (EU, WCO, WTO) regarding trade and classification using INN/CAS.