2008-11-08-世界卫生组织-INN_47th_Executive_Summary_7页_100kb

Summary of the 47th Consultation on International Nonproprietary Names for Pharmaceutical Substances (INN)

Core Content

The 47th Consultation on INN was held in Geneva from 18–20 November 2008, involving members of the INN Expert Group, the INN Advisory Group on biologicals, the full INN Secretariat, and several specialists. The meeting focused on the nomenclature of pharmaceutical substances, particularly monoclonal antibodies (mAbs) and other biologicals, as well as data management and collaboration with international organizations.

Main Points and Recommendations

Nomenclature for mAbs

• 122 INNs were discussed, including 84 new requests, 29 outstanding, 6 previously selected with objections, and 3 substitution requests.
• 106 new names were selected for publication in List 101, while 10 were deferred.
• Three names were rejected due to non-conformity with INN criteria.
• The stem -mab was retained for all mAbs, including Fab fragments, to avoid confusion.
• Substems for origin and disease indication were considered but deemed too complex.
• The group suggested using -t instead of -tu(m) for shorter names, and -l for receptor-related names.
• Greek letter suffixes may be used for mAbs with the same amino acid sequence but different glycosylation patterns.
• Revisions to the A&U (Action and Use) statements were proposed, with a focus on clarity and consistency.
• A subgroup was formed to examine the draft A&U revision and report back.

Definitions for EPOs

• Definitions for EPOs were found inadequate due to lack of glycosylation data.
• Glycosylation patterns vary slightly among EPOs, with minor glycans and differences in terminal structures.
• More detailed data is now expected due to advancements in analytical techniques.
• Linguistic challenges exist in describing complex glycosylation structures in Definitions.

Action and Use (A&U) Statements

• A&U statements are used to classify drugs pharmacologically and are based on applicant declarations.
• Since 1988, A&U statements have been published separately in pINN lists.
• The 1997 revision of A&U terminology included 175 preferred terms, and a draft revision was tabled.
• Guidelines for formulating A&U statements and preferred expressions were proposed.
• A&U statements are not revised and do not appear in the rINN list, unlike national publications such as BAN, JAN, and USAN.
• There was a suggestion to use mode of action (MOA) instead of A&U statements for better classification.

Data Management

• A web-based data management system was developed for INN applications, with high security and user certification required.
• The system is not publicly accessible and will be used for the next INN Consultation.

Collaborator Updates

• EMEA reported on the implementation of the revised 'Guideline on the acceptability of names for human medicinal products' and noted that 80% of objections were due to potential confusion with existing names.
• WIPO is enhancing cooperation with INN, including improved access to INN lists and future presentations.
• USAN reported 118 names adopted by the end of October 2008, and has successfully had a U.S. trademark abandoned for tasimelteon.
• BAN updated to include the 2009 British Pharmacopoeia.
• FDA is increasing interest in naming biologics and has started using the active moiety in monographs.
• IUPAC is working on harmonizing nomenclature with INN and revising the 'Blue Book' for organic chemistry.

Key Information

• New department at WHO: The EMP (Essential Medicines and Pharmaceutical Policies) was created by merging PSM and TCM.
• INN Programme Manager Dr. Raffaella Balocco Mattavelli expressed appreciation for expert contributions.
• Future steps: The working group's recommendations will be reviewed at the next INN Consultation in spring 2009.
• Collaboration: Continued cooperation with EMEA, WIPO, USAN, and others is emphasized for effective nomenclature and data sharing.

Conclusion

The meeting was productive, with significant progress made in nomenclature standards for mAbs and EPOs, and improved data management systems. The INN Programme remains a critical component in ensuring clear, consistent, and globally accepted pharmaceutical naming conventions.