2016-07-08-世界卫生组织-INN_62nd_Executive_Summary_16页_351kb

Executive Summary of the 62nd Consultation on International Nonproprietary Names for Pharmaceutical Substances

The 62nd Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva from April 12-15, 2016, focused on expanding the INN system to address new pharmaceutical challenges and enhancing global accessibility and safety. Key discussions covered the selection and assignment of INN names, proposed changes to nomenclature, and stakeholder perspectives on innovative programs.

Over 183 INN requests were reviewed, with 149 names selected for potential publication in the Proposed INN (p.INN) list and 29 deferred for future consideration. The INN selection process involves expert review, an online system for comments, and a verification phase with applicants. Stakeholders expressed strong interest in biologics naming, leading to agreement on a provisional Biological Qualifier (BQ) system to improve biosimilar identification, accompanied by a call for an impact study due to concerns over complexity and lack of standardization.

New initiatives included the proposed "School of INN" to educate on INN structure and promote global use, addressing current educational gaps among healthcare professionals and students. Ongoing reframes focused on clarifying INN stems and definitions, such as reviews for neuroleptics and monoclonal antibodies. Collaborator updates from organizations like the USAN Council, FDA, and WHO highlight harmonization efforts and support for INN-driven programs.

Overall, the meeting underscored the INN's enduring role in global health through improved nomenclature and collaboration.

Major Decisions and Recommendations

• Adoption of 149 INN names for publication in the p.INN list.
• Deferral of 29 requests and rejection of 2 due to non-compliance with INN criteria.
• Proposal for provisional BQ implementation, with a focus on gather ing stakeholder feedback through an impact study.
• Promotion of the School of INN to enhance education and understanding of INN globally.

Key Challenges

• Balancing INN simplicity with the need for scientific accuracy and homogeneity for new therapies.
• Stakeholder divisions on the BQ system's effectiveness, emphasizing the necessity for transparent impact assessment.