2022-02-28-世界卫生组织-WHO_global_benchmarking_tool_plus_medical_devices_rev._VI+_MD_ver._1_-_Registration_and_Marketing_Authorization_74页_782kb

Summary of WHO GBT+Medical Devices for Registration and Marketing Authorization Benchmarking

Overview

The WHO Global Benchmarking Tool Plus Medical Devices (GBT+MD) evaluates the performance of National Regulatory Authorities (NRAs) in registering and marketing authorizing (MA) medical products (including medicines, vaccines, plasma-derived products, and medical devices). The tool focuses on ensuring regulatory processes align with international standards to guarantee product safety, efficacy, and quality. Key areas include legal foundations, organizational structures, human resources, procedural mechanisms, transparency, and performance monitoring.

Main Categories

• Legal Provisions (Indicator MA01): Establishes and enforces legal requirements for MA issuance, product variations, exemptions (e.g., emergencies), and oversight of donated or generic products. Necessitates clear regulations on MA validity, renewal, and conformity (e.g., GMP, QMS).

• Organization and Governance (Indicator MA02): Ensures a defined organizational structure with clear roles, responsibilities, and inter-entity communication protocols to support efficient MA operations.

• Human Resources (Indicator MA03): Prioritizes sufficient, competent, and trained staff, including training plans, job descriptions, and competency profiles to meet regulatory demands.

• Regulatory Procedures (Indicator MA04): Mandates documented and standardized procedures for application assessment, review, variations, criterion consistency, and timelines to guarantee consistency and efficiency in MA decisions.

• Transparency and Accountability (Indicator MA05): Requires public availability of MA lists and summary technical evaluation reports to promote trust and transparency among stakeholders.

• Performance Monitoring (Indicator MA06): Involves monitoring mechanisms like a centralized database and key performance indicators (KPIs) to ensure regulatory outputs are reliable and continuously improved.

Key Features

• Each sub-indicator has a maturity level (1-4) assessing implementation progress, from Not Implemented to Fully Implemented.
• References incorporate WHO guidelines, ISO standards, and global harmonization initiatives (e.g., IMDRF, ICH) to support alignment with best practices.
• Emphasizes the need for vigilance systems, periodic reviews, and emergency protocols to enhance public health impact.