2021-11-28-世界卫生组织-INN_73rd_Executive_Summary_13页_349kb

报告摘要

73rd INN Consultation Summary

Overview

The 73rd International Nonproprietary Names (INN) Consultation was held virtually from October 19-22, 2021, addressing 301 INN requests, including 278 new and 23 outstanding. Results included 287 names selected for publication in Lists 126 and 127, with three requests withdrawn, one modified, four rejected for not meeting INN criteria, and six deferred.

Key Discussions

INN Requests and Nomenclature

301 requests were processed: 278 new (170 biological, 108 chemical), 23 outstanding.
287 names approved; three withdrawn, one modified, four rejected, six deferred.
Two new stems/substems selected, five suffixes promoted, and five stem descriptions reviewed.
New mAb nomenclature scheme proposed: four groups with suffixes -tug, -bart, -mig, -ment.
- Group 1 (monospecific, unmodified): suffix -tug preferred over -cab.
- Group 2 (engineered constant domain): -bart.
- Group 3 (bispecific): -mig.
- Group 4 (fragments): -ment.
INN and trademark conflicts assessed using a decision tree focusing on safety, similarity, and legal status.

INN and Trademark Conflicts

Assessment methods include comparing first five letters, POCA score, look-alike/sound-alike analysis, and expert review.
A decision tree was proposed for internal use to evaluate coexistence of INN and trademarks safely.

Collaborations and Updates

WHO Units: INN Unit Head thanked for support; SoINN website expanded to three languages with courses on pharmacological classes.
ANVISA (Brazil): Rebuilt committees, approved 78 new names.
IUPAC: Updated nomenclature recommendations, including flavonoids.
PMDA (Japan): Virtual meetings, new JAN names published.
TGA (Australia): Assessed COVID-19 vaccines, noted nomenclature challenges.
USAN: Summer meeting reviewed 35 names, 223 applications processed by Oct 2021.
FDA: CBER handles naming in-house; USAN/FDA collaboration ongoing.
USP: eCommerce site launched, focusing on manufacturing and drug dictionaries.
WHO Collaborating Centers: Assigned ATC codes, DDDs, discussed immunosuppressants and pharmacovigilance.

Stakeholder Engagement

Open session discussed biosimilar naming, with ASBM supporting distinguishable suffixes for safety and pharmacovigilance.
Challenges include inconsistent nomenclature and need for harmonization, especially for biosimilars.