2011-08-08-世界卫生组织-INN_52nd_Executive_Summary_9页_166kb

报告摘要

Date: April 12-14, 2011, Geneva, Switzerland.
Attendees: INN Expert Group, INN Advisory Group on biologicals, WHO Secretariat (QSM, EMP, EHT sections), intergovernmental organizations (IUPAC, JAN, USP, BAN), WIPO, relevant nomenclature bodies, pharmaceutical companies (Clavis Pharma ASA, Vifor Pharma Ltd - via open session).
WHO Context: EMP (Essential Medicines and Pharmaceutical Policies) merged its INN function with the EHT (Essential health technologies) section for device advice. INN (Quality Assurance and Safety: Medicines) remains active despite staffing challenges. A strategic plan was developed and endorsed.

Discussed: 82 INN requests (60 new, 21 outstanding, 1 previously selected with objection).
Outcome:
- 73 New Names selected for potential publication in List 106.
- 6 Requests Deferred.
- 3 Requests Rejected for not meeting INN selection criteria.
- Amendment planned for List 106.
- 1 Request Withdrawn.
Stems/Suffixes: 6 new stems selected, 2 suffixes promoted to the pre-stem list.

Action Taken: A draft 5-year strategic plan was presented and unanimously endorsed by the Expert Group.
Objectives: Outline INN's global impact, identify stakeholders, propose activities (e.g., developing INN Global Data Hub for free stakeholder access, enhanced collaboration with WIPO/Trademark offices, training programs).
Status: Primarily an internal document initially, acknowledging the dynamic nature of science and technology (especially biology). Requires further refinement based on expert feedback.

Interferon Nomenclature Review: Revisions implemented to resolve inconsistencies. While challenging to change existing names, rules were updated for future INN assignment. Related sections of the Bioreview guideline were updated.
Guidance for Composite/Related Substances: Draft guidance presented on creating modified INNs (INNM) for salts, esters, and other chemical modifications. Also addressed naming conventions, recommendations for reversal of word order, and exceptions like racemic mixtures/single enantiomers. The INNM approach has no formal list but is acknowledged; incorrect naming can lead to ambiguity. Guidance aims to help external bodies and clarify past issues, with future versions desirable for wider use.

WIPO: Collaboration focuses on improving trademark office access to INN databases. WIPO supports INN protection.
BAN: Focuses on publishing the 2012 book, integrating biosimilar naming, and interacting with regulatory bodies.
Norwegian WHO Collaborating Centre: Maintains and updates ATC/DDD system and collaborates on antimicrobial surveillance.
USP: Continues to refine naming conventions, discussing practices like using "hydrochloride".

Progress: An online application system for INN submissions has been successfully used (>15 applications). Data management and submission processes improved.
Goals: Inclusion mandatory; development of a global INN data hub for data integrity, national access (controlling INN data ownership), and potential linking with other databases.

Format: Presentations followed by expert discussion, no decisions taken (decisions happen at the closed plenary).
Discussions: Addressed requests from Clavis Pharma (gemcitabine elaidate->elaflurabine) and Vifor Pharma (PA21=β-FeOOH sucrose complex, need for name beyond just the active moiety). Stakeholder presentations informed the closed session deliberations. Applicants must accept proposed names for publication.

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