2022-12-14-世界卫生组织-Status_of_regulatory_and_ethics_procedures_16页_640kb

Summary of WHO Regulatory and Ethics Procedures Status for WHA 75.8 Report

This analysis, based on WHO benchmarking data from 2016 to December 2022, covers regulatory and ethics procedures for vaccines and medicines across 34 countries. Key findings include:

• Regulatory system maturity levels: ML1 (38% of benchmarked countries, or 50% of all WHO member states), ML2 (53% of benchmarked countries, 20% of member states), ML3/4 (9% of benchmarked countries, 29% of member states).
• Trends show progress since 2018, with advancements in indicators such as legal provisions for clinical trials and ethics committee operations.
• Amendments aim to strengthen systems under WHA Resolution 67.20, with countries like China and Singapore achieving higher maturity levels.
• Approximately 73-70% of ML1/ML2 countries are ineligible for WHO Emergency use listing or prequalification due to weaker systems.