2012-03-19-世界卫生组织-Assessment_criteria_for_national_blood_regulatory_systems_40页_929kb

Summary of WHO Assessment Criteria for National Blood Regulatory Systems

This document outlines the essential elements and core regulatory functions required for an effective national regulatory authority (NRA) to regulate the quality, safety, and efficacy of blood, blood components, plasma-derived medicinal products, associated substances, and medical devices including in vitro diagnostics. The criteria are categorized into:

Essential Elements

1. National regulatory system structure: Establishes the legal basis and authority.
2. National regulatory authority (NRA): Defines its scope and responsibilities.

Core Functions (Required [R] and Suggested [S])

• Licensing/Registration: Blood establishments and manufacturers.
• Approval: Product and process approvals for blood and plasma-derived products.
• Regulatory Oversight: Including inspections, vigilance, and traceability.
• Access to Independent Laboratories.
• Clinical Trial Control.
• Lot Release Systems.
• International Cooperation.

Key Outcomes

• Strengths & Gaps Assessment: Helps NRAs evaluate performance and prioritize capacity-building efforts.
• International Alignment: Promotes harmonization of regulations globally, enhancing safety and availability.
• Implementation: Self/external assessments using these criteria identify areas for improvement and guide future regulatory developments.

Countries may fulfill criteria in different ways, but adherence to these standards is crucial for ensuring blood product safety.