2015-05-30-世界卫生组织-Biological_Qualifier_An_INN_Proposal_-_June_2015_8页_218kb

报告摘要

Biological Qualifier (BQ) Proposal Summary

Introduction

This document proposes a voluntary, global system for assigning Biological Qualifiers (BQ) to biological active substances with International Nonproprietary Names (INN). It addresses challenges in naming and identification associated with biological medicines, such as glycoproteins and biosimilars, to reduce errors in prescription, dispensing, pharmacovigilance, and international prescription transfers.

Purpose and Scope

The BQ is a random alphabetic code assigned to biological substances, used alongside INN for unique identification.
It applies to all biological active substances with INNs, potentially retrospectively, but excludes certain products like vaccines and impure mixtures.
The scheme is voluntary, self-funding through application fees, and overseen by the WHO INN Expert Group and administered by the WHO INN Secretariat.

Key Features of BQ

Code Structure: Composed of four random consonants, providing over 160,000 unique codes.
Application: Submitted by corporate bodies (BQ Applicants) during marketing authorization processes or required by regulatory authorities.
Usage Assistance: Aids in identifying substances for prescribing, dispensing, pharmacovigilance, and global prescription transfer, acting as a cross-check for other information.

Management and Access

Database Security: A secure WHO database stores application details and updates, with read-only access for regulatory authorities and applicants.
Confidentiality: All submitted information is confidential, with public data shared except for sensitive commercial details.

Intended Users and Benefits

Stakeholders: Regulatory authorities, health authorities, pharmacists, healthcare professionals, and patients can use BQ for identification, decision-making, and monitoring.
Benefits: Reduces errors by providing a harmonized global system, avoiding proliferation of national qualifier schemes, and enhancing transparency and safety in healthcare.

The BQ scheme will be used in conjunction with the existing Greek letter INN system until BQ is comprehensively adopted.

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