2022-03-30-世界卫生组织-Interim_manual_for_the_performance_evaluation_of_regulatory_authorities_seeking_the_designation_as_WHO_listed_authorities_236页_2mb

This text provides a comprehensive guide for evaluating and designating WHO-listed authorities (WLAs) for various regulatory functions related to medical products. The process involves multiple steps: evaluating eligibility, using a performance evaluation framework (PEF), which includes mandatory Global Benchmarking Tool (GBT) sub-indicators and performance evaluation indicators, and conducting expert reviews for certain functions. Key functions covered are Regulatory System (RS), Registration and Marketing Authorization (MA), Vigilance (VL), Market Surveillance and Control (MC), Licensing Establishments (LI), Regulatory Inspection (RI), Laboratory Testing (LT), Clinical Trials Oversight (CT), and RA Lot Release (LR). Each function has detailed methodologies, performance indicators, and evaluation tools to assess maturity levels and ensure adherence to Good Practices (GxP). The goal is to promote global public health by identifying authorities capable of ensuring the safety, efficacy, and quality of medical products. The process is time-bound and involves multi-country expert teams, field visits for vigilance, and tools like the GBT and PEF scorecards.