2016-02-02-世界卫生组织-WHO_Call_for_Expression_of_Interest_for_proposal_submissions_for_Biological_Qualifier_Impact_Assessment_Study_17页_221kb

Summary of WHO Biological Qualifier (BQ) Front Page Meeting

Purpose and Background

This meeting discussed the development of a global identification system for biological medicines using a Biological Qualifier (BQ) code. The Initiative arose from regulatory requests to avoid proliferation of national schemes, with the BQ being voluntary, separate from INN, and applicable to all biologicals. The INN Expert Group oversees development, and the Secretariat manages a secure database.

Key Proposals

• BQ Features: A 4-letter code (with potential checksum for accuracy), applied to applicants (not manufacturing sites), voluntary, and providing a historical record of registrations.
• Update: Based on stakeholder feedback, biosimilars references were removed, and the code aims to enhance tracking and pharmacovigilance without altering existing INN names.

Stakeholder Feedback

• Support: Generally well-received by clinical, industry, and academic groups, with majority respondents endorsing the scheme.
• Opposition: Noted from industry associations like ALIFAR (Latin America) and Brazil's mission, citing potential confusion, market impact, and concerns over data confidentiality and unnecessary complexity.
• Mixed Views: Government agencies and health ministries divided opinions, with some governments (e.g., Canada) supportive and others weary, though EMA remained neutral.

Key Issues and Next Steps

• Clarifications Needed: Definition of "BQ applicant," code format (including checksum needs), retrospective application feasibility, and database confidentiality.
• Proposed Actions: A revised draft will be presented at the October 2015 INN Consultation; a pilot scheme or training may be considered to assess impact.
• Fees: No final fee decided, but charged with a lower amount than INN applications.
• Outcomes: The consultative process continues, with focus on global harmonization to improve patient safety and regulatory efficiency.