2015-09-29-世界卫生组织-Biological_Qualifier_an_INN_Proposal_5页_119kb

INN Biological Qualifier (BQ) Proposal Summary

This document proposes a global system for assigning Biological Qualifiers (BQ) to biologic substances with International Nonproprietary Names (INNs). The aim is to provide a unique identifier for these substances, facilitating prescription, pharmacovigilance, and global prescription transfer. Unlike traditional chemical INNs, BQ addresses the complexity of biologic medicines, such as antibodies or glycoproteins, which can vary in formulation and have different clinical profiles.

The BQ code consists of four random consonants in two-letter blocks, optionally with a two-digit checksum for error detection. It is designed to be user-friendly, drawing inspiration from car registration plates, and can reach approximately 160,000 variants, ensuring scalability.

The system is voluntary, proposed by the Programme on International Nonproprietary Names under WHO. BQ Applicants, typically corporate bodies controlling global manufacturing, apply for codes through an automated WHO system and pay an initial fee for self-funding. Updates to product details, such as marketing authorizations or manufacturing sites, must be reported promptly to keep data current.

Managed by the WHO INN Secretariat, a secure database stores BQ information. All stakeholders, including regulatory authorities and applicants, gain read-only access to non-confidential data. The scheme promotes uniform global identification, reducing fragmented national systems. Benefit recognition requires broad adoption, driving implementation worldwide. Thus, BQ enhances machine-readable health information and supports patient safety.