2023-01-18-世界卫生组织-INN_75th_Executive_Summary_14页_236kb

Summary of 75th Consultation on International Nonproprietary Names for Pharmaceutical Substances (December 2022)

Overview: The 75th INN Consultation was held in Geneva from October 18-21, 2022, focusing on pharmaceutical substance naming. Key topics included monoclonal antibody nomenclature, cell therapy naming complexities, peptide naming harmonization, and updates from international partners. A total of 259 requests were reviewed, with 247 INNs selected, six deferred, and six not meeting criteria. Below is a detailed summary.

Executive Summary

• The meeting aimed to address challenges in pharmaceutical naming, emphasizing the need for harmonization and clarity.
• Decisions were made on monoclonal antibody suffixes (-bart vs -tug), cell therapy Definitions, and peptide mixtures.
• Collaborations with organizations like WHO, USAN, and WIPO were highlighted for global harmonization.

Key Outcomes

• Monoclonal Antibody Nomenclature: The -tug suffix was reaffirmed for natural immunoglobulins, while -bart was reserved for engineered variants. IMGT GapAlign will be incorporated to define mutations more accurately.
• Cell Therapy Naming: Extended Definitions are needed to prevent INN changes with manufacturing alterations. A study on look-alike, sound-alike (LASA) errors suggested keeping names short and unique to minimize risks; recommendations include limits on syllable count and stem usage.
• Peptide Naming: Harmonization with USAN was proposed. Mixtures of up to five components should be named individually; combinations exceeding this may use stems like -imut if well-defined.
• International Collaborations: Partner updates included WHO-INEE cube method for side effect coding, IDMP standards, and efforts to increase pharmacovigilance through distinguishable naming.

Stakeholders Sessions

• Heartseed: Requested minor adjustments to the Definition of remumiocel to accommodate future manufacturing changes.
• ISA Therapeutics: Advocated for harmonized naming with USAN to allow a single unique name for peptide mixtures.
• Alliance for Safe Biologic Medicines (ASBM): Emphasized the need for harmonized INN to improve pharmacovigilance and biosimilar substitution.
• Redx Pharma: Requested a distinct suffix for porcupine inhibitors to avoid confusion with Wnt inhibitors using the -vivint stem.

Preparations for Future Meetings

• The 76th INN Consultation is scheduled for March 15-18, 2023, in Geneva.
• The INN Program continues to balance nomenclature rules with scientific advancements and user feedback.

Conclusion

The consultation underscored the importance of clear, harmonized naming to support global health, manufacturing stability, and patient safety. Future discussions will focus on ongoing harmonization efforts and addressing emerging challenges in pharmaceutical nomenclature.