2015-12-08-世界卫生组织-INN_61st_Executive_Summary_16页_248kb

Summary

Background

The 61st Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances was held in Geneva on October 13-16, 2015. It addressed challenges in naming biological substances, including a record number of 135 new applications. The focus included trends in INN requests (e.g., 45% of applications now biological) and the discussion of the Biological Qualifier (BQ), a proposed global system for naming biological drugs.

INN Nomenclature

• 182 INN requests were reviewed (135 new, 43 outstanding, 4 previously proposed).
• 154 INN names were selected, 18 deferred, and 5 rejected due to non-compliance with selection criteria.
• Stems and suffixes were updated; three new stems/substems and three suffixes were promoted.

Biological Qualifier (BQ)

• The BQ is a four-letter random code for identifying biological drug substances, not tied to proprietary names. It aims to aid tracking and harmonize international naming.
• Stakeholder feedback: Approximately two-thirds agreed partially/fully with the BQ proposal, noting challenges in memorability and integration. Countries like the US and EU varied in support, with concerns from organizations like EGA and GPhA about complexity and utility.
• WHO proposed adoption, contingent on a three-year pilot study for impact assessment, with a recommendation for NRAs to align if adopted.

Stakeholder Updates

• FDA: Draft guidance on non-proprietary naming of biologics includes a four-letter suffix, similar to BQ, but critics argue for clearer meaning.
• EMA: Supports use of invented names for tracking but opposes BQ for biosimilars.
• TGA (Australia) and PMDA (Japan): Alignment with international systems is desired, but current schemes may persist for compatibility.
• Cell Therapy Nomenclature: A simplified scheme was adopted, retaining a '-cel' suffix with cell-type identifiers.
• Antibody Drug Conjugates: Prefixes like '-ado-' were proposed to reduce error risks, but further evaluation is needed.

Collaboration and Other Topics

• International updates from organizations like IUPAC, IUBMB, BP, and EDQM highlighted harmonization efforts in various naming systems.
• The session concluded with consensus on BQ adoption and a pilot implementation plan, underlining the need for global coordination in pharmaceutical naming.

Conclusion

The INN Expert Group recommended adopting the BQ system, with WHO urged to conduct an impact assessment in a pilot study, potentially leading to wider implementation to ensure public health safety and standardization.