2022-03-30-世界卫生组织-Interim_operational_guidance_for_evaluating_and_publicly_designating_regulatory_authorities_as_WHO_listed_authorities_47页_1mb

Interim Operational Guidance for WHO Listed Authorities (WLA)

Purpose and Scope

• Purpose: To provide a transparent, evidence-based pathway for globally recognizing regulatory authorities (NRAs/RRS) as meeting international standards for medical products oversight.
• Guidance Version: 1.0 (under review for amendments based on 2022 framework implementation).

Key Components

1. Performance Evaluation Framework (PEF)

   • Evaluates technical (e.g., decision-making quality) and operational (e.g., timelines) performance of RAs.
   • Indicators: Mandatory GBT sub-indicators (GBPs) and specific regulatory function outputs (Tables 3, 4; PEF manual).
   • Pathways:
     • Abridged: For SRAs/Highly Performing NRAs.
     • Streamlined: For tWLAs (Transitional List).
     • Standard: For other NRAs (post-GTB benchmarking).

2. Transitional Arrangements

   • tWLA List: Replaces the 2019 Interim List; authorities transition via a time-bound evaluation process.
   • Maximizing Efficiency: Prioritizes resources for eligible, high-impact regulatory systems.

3. Application Process

   • Steps:
     1. Expression of Interest (EOI) (Annex 1).
     2. Evaluability Check: Compliance with eligibility criteria (tWLA list, overall ML3).
     3. Agreement: Roadmap for evaluation (Annex 2) specifying scope, timelines, and responsibilities.
     4. PEF Execution: Mix of desk audits and site visits (if needed).
     5. WLA Opinion: Advisory Group (WAG) reviews findings (Annex 4).

4. Listing and Renewal

   • Validity: Initial listing for 5 years; thereafter continuous monitoring.
   • Renewal: Requires evidence of sustained performance via periodic reporting (Annex 5).

Core Principles

• Good Regulatory Practices (GRP): Emphasis on transparency, regulatory cooperation, and efficiency (Annex 7).
• Risk-Based Approach: Tailored evaluations leverage existing data (Section 7.4).
• Ongoing Monitoring: Continuous assessment via Renewal Reporting Forms and WHO notifications (Section 8).

Delisting Considerations

• Triggers: Major reorganization, breach of listing conditions, or invalid reliance (Section 9.2).
• Process: Re-evaluation (may lead to delisting without WAG if urgent public health risks exist).

Supporting Frameworks

• Annexes: EOI template (Annex 1), Agreement Contract (Annex 2), WLA sample output (Annex 3).
• Manuals: GBT, PQ program integration, Renewal process timelines.