2024-05-21-世界卫生组织-INN_78th_Executive_Summary_15页_371kb

Summary

The 78th Consultation on International Nonproprietary Names for Pharmaceutical Substances, organized by WHO, was held from March 18–22, 2024, addressing 261 new requests (129 chemical and 132 biological), 22 outstanding requests, and various objections. A total of 270 new names were approved, with some deferred or rejected due to non-compliance with guidelines. Decision-making focused on standardizing nomenclature, particularly for heterobifunctional protein degraders and variant COVID-19 vaccines.

Key discussion topics included:

• Abolishing the use of "-domide" stems for heterobifunctional protein degraders, opting instead for "-deg-" infixes/suffixes.
• Revising Working Document 21.520 for COVID-19 vaccines to revert to standard fee structures and eliminate accelerated timelines for all variants.
• Proposing a "-va-" infix for prophylactic mRNA vaccine substances, enhancing distinction from therapeutic mRNA vaccines, though options for other mRNA categories remain under review.
• Addressing technical nomenclature issues, such as correcting the structure for propagermanium and reviewing descriptions for existing stems.

Organizational updates from collaborators include new divisions at WHO (Health Product Policy and Standards, Regulation and Prequalification, Innovation and Emerging Technologies), planning for the School of INN, and beta launches for the Open Database for Proteins project to improve data accessibility. Stakeholder sessions explored nomenclature changes for specific drugs, reinforcing the need for flexibility and international standards.

The consultation concluded with plans for the 79th meeting and advocacy for distinct INN suffixes for biologics, amid ongoing efforts to harmonize global pharmaceutical nomenclature.