2025-06-25-世界卫生组织-INN_80th_Executive_Summary_15页_408kb

Analysis and Summary of the 80th INN Consultation

The 80th International Nonproprietary Names (INN) Consultation, held virtually and in-person in Geneva from March 18-21, 2025, focused on assigning INN names to new pharmaceutical substances and addressing global health challenges. The meeting, led by Assistant Director-General Yukiko Nakatani, emphasized INN's role in ensuring patient safety, equitable access to medicines, and regulatory harmonization. Key topics included the processing of INN requests, updates to nomenclature databases, and collaborations with stakeholders.

A total of 255 INN requests were evaluated, leading to the selection of 239 new names and deferring seven for future discussion. Issues such as sequence verification for monoclonal antibodies (mAbs) and the management of multiple variants in products like Adzynma were highlighted. The Open Database for Proteins contained structural data for 1,200 substances, with plans to update it post-meeting.

Working groups explored specialized areas: the Cell Therapy group dealt with suffix selection for gene therapies like CAR-T cells, while the Monoclonal Antibodies group underscored the need for automated naming conventions to avoid errors. The Publication group discussed standardizing definitions and exploring use cases like pharmacovigilance, where INN stems could detect adverse drug reactions.

Collaborations with global health agencies, including AEMPS, EMA, PMDA, and ISMP, reflected INN's expansion into biologics and emerging therapies. The 2025 work included integrating INN with systems like ATC codes and advancing the School of INN to train professionals worldwide.

The Open Session featured stakeholder inputs, such as proposals for distinct nomenclature to enhance biosimilar safety and international harmonization efforts. The meeting concluded with the 81st Consultation scheduled for October 2025.