A preliminary analysis of WHO's initiatives and tools for promoting the improvement of medical product regulatory capacity worldwide(part I):the core content of global competency framework for regulators of medicines and guidelines for advancing smart regulation
ZHANG Yan-ling
MA Ming-shu
WANG Yi-fei
SHAO Rong
Abstract：As a specialized agency of the United Nations,the World Health Organization(WHO)is dedi-cated to promoting the effective regulation of medical products across countries,ensuring that medicines,vaccines,and medical devices can sustain the normal functioning of national health systems and enable individuals from dif-ferent countries to access high-quality health support.Since 2014,WHO has launched the regulatory systems strengthening(RSS)program for medical products,adopting a series of initiatives to develop a comprehensive framework that guides countries in enhancing their medical product regulatory capacities and provides crucial sup-port for the coordinated improvement of regulatory capabilities on a global scale.This paper focuses on explaining the core initiatives under the RSS program,including the quality management system(QMS),good regulatory practices(GRP),good reliance practices(GRelP),and global competency framework(GCF),which is expected to provide references and insights to accelerate the modernization of drug administration and enhance the interna-tional competitiveness of the pharmaceutical industry in China.
Keywords：WHOregulatory systems strengtheningquality management systemgood regulatory prac-ticesgood reliance practicesglobal competency framework
Publication Date：2026-04-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 812-818 )