2015-09-29-世界卫生组织-Biological_Qualifier_Frequently_Asked_Questions_10页_160kb

Biological Qualifier (BQ) Frequently Asked Questions Summary

Overview

The BQ is a voluntary coding system developed by the WHO to uniquely identify biological active substances, complementing the INN. It aims to harmonize global pharmacovigilance, prescription, and dispensing processes.

Key Objectives

• Minimize errors in drug handling by providing a unique identifier for biological substances.
• Enable global traceability and facilitate rational prescription and use.
• Serve as an alternative to proprietary names in regulatory and pharmacovigilance systems.

Biological Medicinal Products

• Defined as medicines derived from humans, animals, or biotechnology with an INN.
• Includes biotherapeutic proteins, purified proteins, polysaccharides, and other specified substances, with broad applicability to all biological medicines.

BQ Application and Scope

• Applies to all biological medicines that have an INN, excluding certain vaccines, impure mixtures, and specific products without INNs.
• BQ is not mandatory but voluntary; retrospective application is under investigation.
• It identifies the drug substance, not the drug product, though used with INN for product-related purposes.

Code Format

• Comprises four random consonants, optionally with a two-digit checksum for error detection.
• Purpose of checksum is to detect transcription errors in software systems.

Purpose and Benefits

• Uniquely identifies biological active substances for safer global operations.
• Helps in prescription, dispensing, pharmacovigilance, and prescription transfer.
• Does not affect access to biosimilars, as it was not intended for that purpose; Greek letter system for glycoforms is retained initially.

Application Process

• Submitted by corporate entities managing global manufacturing to the WHO INN Secretariat.
• Automatically issued via online system and updates managed collaboratively by applicants, MAHs, and regulators.

Database and Access

• Contains applicant details, INN, BQ, marketing authorization data, and manufacturing sites.
• Accessed by WHO personnel for editing, regulatory authorities for read-only, and applicants for updates and tracking.
• Publicly available information enables cross-reference and decision-making in healthcare.

Questions Addressed

• BQ is not part of INN; it's an additional element.
• It is not mandatory but voluntary, with potential for retrospective use.
• BQ codes may change if active substances undergo significant changes, but hyperlinks in the database facilitate data consistency.
• The system does not replace the Greek letter qualifier for glycoforms; both are used concurrently at present.