2021-06-07-世界卫生组织-INN_72nd_Executive_Summary_14页_254kb

72nd Consultation on International Nonproprietary Names for Pharmaceutical Substances Summary

• The meeting address was held virtually from April 13-16, 2021, Geneva, with Dr. Clive Ondari opening the session and thanking contributors.
• Key discussions included the classification of single- and multi-specific monoclonal antibodies (mAbs), proposing new stems and suffixes to simplify naming and reduce confusion.
• Of 263 requests reviewed, 249 names were selected for publication in Lists 125 and 126, while some requests were deferred or require modifications.
• The working group proposed grouping mAbs to avoid overcrowding, with recommendations for trademarks, as well as new prefixes for cardiovascular drugs.
• For COVID-19 vaccines, a consensus was reached on using short syllables for variants of concern (VOC), with process acceleration to support rapid response.
• INN trademarks and conflicts were debated, challenging the short-5-letter comparison approach and suggesting broader assessments.
• SoINN saw updates to its website and educational materials, becoming a highly visited resource for INN knowledge.
• INNM and stereochemistry documents were improved, addressing issues like radio-isotopic complexes and isomer prefixes.
• Collaboration updates from international organizations (e.g., EDQM, IUPAC, PMDA) discussed pharmacovigilance, serialization, and quality standards.
• Stakeholder sessions highlighted challenges in biologic naming, patient safety, and pharmacovigilance challenges like brand misidentification in adverse drug reports.
• The meeting concluded with a plan for future expansion and an agreed date for the next consultation.