A preliminary analysis of WHO's initiatives and tools for promoting the improvement of medical product regulatory capacity worldwide(part Ⅱ):key requirements for the global benchmarking tool and the WHO-listed authorities framework
ZHANG Yan-ling
MA Ming-shu
WANG Yi-fei
SHAO Rong
Abstract：The WHO launched the regulatory system strengthening program for medical products in 2014,aiming to encourage the enhancement of medical product regulatory levels in countries and promote the coordinated development of regulatory capabilities globally.This initiative encompasses guidelines on quality management systems,good regulatory practices,good trust practices,and a global regulatory capacity framework.Its core tools are the global benchmarking tool(GBT)for regulatory system assessment and the WHO-listed authorities(WLA)framework built upon the GBT.Understanding the assessment requirements of the GBT and WLA can not only provide ideas for improving China's drug regulatory system but also serve as a reference for aligning regulatory work with international standards.This paper systematically introduces the assessment dimensions and key requirements of the GBT and WLA in order to explore their intrinsic relationship with relevant guiding principles.
Keywords：WHOregulatory systems strengtheningglobal benchmarking toolWHO-listed authoritiesperformance evaluation
Publication Date：2026-05-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 924-931 )